Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells. Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Rash leading to dose reduction occurred in 5% of patients, and RYBREVANT was permanently discontinued due to rash in 0.7% of patients. Development Pipeline Select programs in development, Phase 1 through Approval (removed after programs achieve approval in both US/EU) Novel Therapies Select Novel Therapy programs recently approved or with potential filings in the US/EU within a specified window as outlined in the Pharmaceutical Business Review. Proc Natl Acad Sci USA. Today's BTD marks the 11th received by Janssen's Oncology Therapeutic Area. The median time to onset was 1.5 hours (range: 0 to 73 hours). In the study, 94.1 percent of patients at the RP2R and 96.8 percent of the overall study population had one or more treatment-emergent adverse events (TEAEs). Recurrent Grade 3 or 4 neutropenia, thrombocytopenia, lymphopenia and anemia were seen in 63% (61/97), 18% (17/97), 60% (58/97), and 37% (36/97) after recovery from initial Grade 3 or 4 cytopenia following infusion. In May 2022, Janssen announced that the European Commission (EC) granted conditional marketing authorisation of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances and polyradiculoneuritis. [5], Multiple myeloma is the second most common form of blood cancer, [6] and it is slightly more common in men than women. P-gp, BCRP, or OATP1B1 Substrates Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Ocular Toxicity17RYBREVANT can cause ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, and uveitis. Of the 140 systemic administration-related reactions that occurred in 77 patients, 121 (86%) occurred on the day of DARZALEX FASPRO administration. Horsham, PA: Janssen Biotech, Inc. [18] Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non-Small Cell Lung Cancer V.3.2022. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00153920. Increases in phosphate levels are a pharmacodynamic effect of BALVERSA [see Pharmacodynamics (12.2)]. [23] ClinicalTrials.gov. Hyperphosphatemia and Soft Tissue Mineralization BALVERSA can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis and vascular calcification. [8] Clinicaltrials.gov. 2013;110:5145. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed. At EHA, additional data from the CAPTIVATE study will focus on synergistic activity and immune restoration with this combination regimen. Janssen to Highlight Science, Innovation and Advances in Robust Oncology Portfolio and Pipeline Through More Than 60 Data Presentations at ASCO and EHA. Withhold, dose reduce or permanently discontinue RYBREVANT based on severity. Withhold, dose reduce, or permanently discontinue BALVERSA based on duration and severity of hyperphosphatemia [see Dosage and Administration (2.3), Table 2: Dose Modifications for Adverse Reactions]. Forty-four (45%) patients received only tocilizumab, of whom 33 (34%) received a single dose and 11 (11%) received more than one dose; 24 patients (25%) received tocilizumab and a corticosteroid, and one patient (1%) received only corticosteroids. The most common hematologic laboratory abnormalities (40%) with DARZALEX are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia. Type and screen patients prior to starting DARZALEX and DARZALEX FASPRO. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. The interim analysis comprises a patient population with 32 distinct solid tumor histologies. Available at: https://clinicaltrials.gov/ct2/show/NCT04538664. [25] Ahn, J. et al. Janssen's Multiple Myeloma Strategy Add a personalized message to your email. You need JavaScript enabled to view it. To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX infusions. Three patients (1%) discontinued RYBREVANT due to ILD/pneumonitis. ADVERSE REACTIONS The most common adverse reactions (10%) that occurred more frequently in the ERLEADA-treated patients (2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion. Johnson & Johnson assumes no obligation to update this information. CSR/RPED resolved in 13% of patients and was ongoing in 13% of patients at the study cutoff. Accessed May 2022. Treat promptly and manage appropriately according to the severity of the hypersensitivity reaction. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. [13][14], We're concentrating on developing targeted therapies for patients with lung cancer, the leading cause of cancer deaths in men and women globally. Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. 13 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died. PRIME Factsheet. The most common adverse reactions with combination therapy (20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. Use caution if substrates of P-gp, BCRP, or OATP1B1 must be co-administered with ERLEADA and evaluate for loss of activity if medication is continued. In patients with mild or moderate impairment, reduce recommended IMBRUVICA dose and monitor more frequently for adverse reactions of IMBRUVICA. Learn More Capabilities Discovery and Early Development Translational Research and Diagnostics Late Development Immune Therapy Cancer Interception and the Tumor Microenvironment Commercialization Focus Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. [15] Cancer.Net. 8Benonisson H et al. Parkinsonism and Guillain-Barr syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI. For more information, visit: https://www.RYBREVANT.com. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS. Multiple myeloma: causes, risk factors, and prevention. *Accelerated approval was granted for MCL and MZL based on overall response rate. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose. BMC Cancer. var addy2870 = 'info' + '@'; In December 2017, Janssen Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI. About CARVYKTICARVYKTI (cilta-cel) received approval by the U.S. FDA in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.10 CARVYKTI is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patients own T cells with a transgene encoding a chimeric antigen receptor (CAR) that directs the CAR positive T cells to eliminate cells that express BCMA. Accessed May 2022. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. [2], Incident cases from 1990 to 2016 increased by 126% globally and by 106% to 192% for all SDI quintiles. Deaths due to cardiac causes or sudden deaths occurred in 1% of 4,896 patients who received IMBRUVICA in clinical trials, including in patients who received IMBRUVICA in unapproved monotherapy or combination regimens. Data at ASCO and EHA will span frontline and relapsed or refractory settings with the latest updates from two investigational therapies and two approved treatments. What is B-Cell Lymphoma: Available at: https://www.webmd.com/cancer/lymphoma/what-is-b-cell-lymphoma#1. Based on the safety population, rash occurred in 74% of patients treated with RYBREVANT, including Grade 3 rash in 3.3% of patients. CSR/RPED led to dose interruptions and reductions in 9% and 14% of patients, respectively, and 3% of patients discontinued BALVERSA. IMBRUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX. There is no panacea. Lancet Oncology. Last accessed: December 2022. The incidence of infusion modifications due to IRR was 62% and 1.3% of patients permanently discontinued RYBREVANT due to IRR. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. The HLH event was preceded by prolonged CRS lasting 97 days. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with ERLEADA and 1.5% of patients treated with placebo. Featured data on CAR-T and Bispecific therapies JAMA Oncol. The most frequent second primary malignancy was non-melanoma skin cancer (6%). The data evaluated HRR gene alterations beyond BRCA1/2, including PALB 2, CHEK2 and other mutations (ASCO Poster Abstract: #5020). Janssen Research & Development, LLC isone of the Janssen Pharmaceutical Companies of Johnson & Johnson. DARZALEX and DARZALEX FASPRO are contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase (for DARZALEX FASPRO), or any of the components of the formulations. Clin Cancer Res. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. It will be the first CAR-T therapy to be approved for . Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO. [_}\,7h/bD)@I@yA g$ E([RdGe:Xv\ In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2018), for exclusive rights to niraparib in prostate cancer. Explore the foundations of MM, including disease pathogenesis, epidemiology, diagnostic methods and measuring treatment response. Find outhowwe work with external companies andorganisations. Milestone Follows European Medicines Agency PRIME Designation for this BCMA Bispecific Antibody for the Treatment of Relapsed or Refractory Multiple Myeloma Monitor patients for signs and symptoms of cranial nerve palsies. Eighty-seven percent (84/97) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Concomitant use of ERLEADA with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. In addition, updated Phase 1b results from the TRIMM-2 study evaluating talquetamab in combination with DARZALEX FASPRO for the treatment of relapsed or refractory patients with multiple myeloma will be highlighted (EHA Oral Abstract: #S183). Please see our Privacy Policy. This site is governed solely by applicable U.S. laws and governmental regulations. You need JavaScript enabled to view it. Do Not Sell or Share My Personal Information, Limit the Use of My Sensitive Personal Information. 2018; 4(9):1221-1227. About LazertinibLazertinib is an oral, third-generation, brain-penetrant, EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR.25 Interim safety and efficacy results from the lazertinib Phase 1-2 study were published in The Lancet Oncology in 2019. Innovation Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory multiple myeloma 3 0 obj Secondary Malignancies: Patients may develop secondary malignancies. Dose modifications of IMBRUVICA are recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. The median onset of parkinsonism in the 5 patients in CARTITUDE-1 was 43 days (range 15-108) from infusion of ciltacabtagene autoleucel. DARZALEX and DARZALEX FASPRO: Embryo-Fetal Toxicity. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Grade 3 or 4 infections occurred in 23% (22/97) of patients; Grade 3 or 4 infections with an unspecified pathogen occurred in 17%, viral infections in 7%, bacterial infections in 1%, and fungal infections in 1% of patients. All contents Copyright Johnson & Johnson Services, Inc. 1997-2023. 2023 Key Events All events were Grade 1-2. Data at ASCO and EHA for the investigational bispecific antibody teclistamab (BCMAxCD3 bispecific antibody) will include an updated analysis from the Phase 1/2 MajesTEC-1 study evaluating monotherapy treatment for patients with relapsed or refractory multiple myeloma (ASCO Oral Abstract: #8007; EHA Poster Abstract: #P921) and results from an analysis of patients who were previously treated with a BCMA-targeted agent (ASCO Poster Abstract: #8013; EHA Oral Abstract: #S184). In January 2021, talquetamab was granted PRIME designation by the European Commission. The most frequently reported adverse reactions (incidence 20%) were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen. Pharmacogenomics also has a critical role in the MM drug pipeline. Janssen Oncology has over ten years experience[11] of research in prostate cancer, the most common cancer among men in the EU. Your doctor will assess your medical . Advise female patients of reproductive potential to use effective contraception during treatment with BALVERSA and for one month after the last dose. All other readers will be directed to the abstract and would need to subscribe. Do Not Sell or Share My Personal InformationLimit the Use of My Sensitive Personal InformationCookie Settings, Pharmaceutical Companies of Johnson & Johnson, Reimagining the Way Healthcare Is Delivered, Advancing New Healthcare Solutions Through Collaboration, Learn About the Company's Rich Heritage at Our Digital Museum. Available at: https://www.env-health.org/IMG/pdf/prostate_testical.pdf. Expert Review of Clinical Pharmacology. Hypersensitivity Reactions have occurred in 5% (5/97) of patients following ciltacabtagene autoleucel infusion. So why should patients? Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients with hypogammaglobulinemia. If serum phosphate is above 7.0 mg/dL, consider adding an oral phosphate binder until serum phosphate level returns to <5.5 mg/dL. Cardiac Arrhythmias, Cardiac Failure and Sudden Death: Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA. PRIME offers enhanced interaction and early dialogue to optimize drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.9, About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.10,11 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. [7] American Cancer Society. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Please see our Privacy Policy. Key Multiple Myeloma Companies: Roche, AbbVie, Janssen Pharmaceutical, Regeneron Pharmaceuticals, Bristol-Myers Squibb, . Teclistamab is currently being evaluated in several monotherapy and combination studies. [1] WHO International Agency for Research on Cancer, Cancer Tomorrow data visualization, 2020. DARZALEX and DARZALEX FASPRO may cause depletion of fetal immune cells and decreased bone density. For nearly 20-years [8], Janssen Oncology has been dedicated to the multiple myeloma community, focused on developing tailored solutions and innovations that can change the face of this complex disease. Even with significant advances in treatment, MM remains a challenging disease. Median time to onset was 26 days (range 21-101 days) following infusion of ciltacabtagene autoleucel. (7.1), Strong CYP2C9 or CYP3A4 inducers: Avoid concomitant use with BALVERSA, Moderate CYP2C9 or CYP3A4 inducers: Increase BALVERSA, Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period. Johnson & Johnson assumes no obligation to update this information. CYP3A Inducers: Avoid coadministration with strong CYP3A inducers. Oncology Human lung bronchioalveolar carcinoma cell At Janssen Oncology, we have a singular focus: the elimination of cancer. ICANS occurred in 23% (22/97) of patients receiving ciltacabtagene autoleucel including Grade 3 or 4 events in 3% (3/97) and Grade 5 (fatal) events in 2% (2/97). The determination of a patients ABO and Rh blood type are not impacted. Hypothyroidism In 2 randomized studies (SPARTAN and TITAN), hypothyroidism was reported for 8% of patients treated with ERLEADA and 1.5% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Thirty-two percent of patients received phosphate binders during treatment with BALVERSA. Learn about whatmakesJanssena great place to work. Leukemia. Please Note: Only individuals with an active subscription will be able to access the full article. Janssen will present baseline patient characteristics and the application of different radiation therapy regimens from the Phase 3 ATLAS study investigating if the addition of ERLEADA (apalutamide) to a gonadotropin-releasing hormone agonist (GnRH) in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival (ASCO Poster Abstract: #5084). Find out more about the evolution of MM. Janssen Pharmaceutical Companies of Johnson & JohnsonSelected NME Pharmaceutical Pipeline -Recent Approvals/Potential Filings*(2019-2023 Key Filings, As Outlined at 2019 Pharm Business Review) Selective Highlights as of January 26, 2021 *Filings/approvals assumed to be in the US and EU unless otherwise noted. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA. Included within dry eye. The combination of DARZALEX or DARZALEX FASPRO with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. For more information, visit www.ERLEADA.com. Lung cancer Updated data will be presented for the bispecific antibody RYBREVANT (amivantamab-vmjw) that highlights Janssens commitment to precision medicine strategies, with an oral presentation of updated results for RYBREVANT as a monotherapy in patients with non-small cell lung cancer (NSCLC) characterized by MET exon 14 skipping mutations (ASCO Oral Abstract: #9008). The National Comprehensive Cancer Network (NCCN), recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and has Category 1 treatment status for treatment-nave patients without deletion 17p/TP53 mutation and as a preferred treatment for treatment-nave patients with deletion 17p/TP53 mutation. These events have occurred particularly in patients with cardiac risk factors including hypertension and diabetes mellitus, a previous history of cardiac arrhythmias, and in patients with acute infections. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies. Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, and PROLONGED and RECURRENT CYTOPENIA. Major hemorrhage ( Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4.2% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA in 27 clinical trials. In January 2021, DARZALEX FASPRO became the first FDA-approved therapy for light chain amyloidosis. However, the MM pipeline is continuously expanding, with a variety of drugs on the horizon. Advise females of reproductive potential of the potential risk to the fetus. Fractures In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. Obtain further evaluation (e.g., ECG, echocardiogram) as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Last accessed: May 2021. Available at: https://ecpc.org/wp-content/uploads/2019/08/ECPC-White-Paper-Bladder-Cancer-EN-1.pdf. *Included within onycholysis. Cranial Nerve Palsies: Three patients (3.1%) experienced cranial nerve palsies in CARTITUDE-1. [9] Multiple Myeloma Research Foundation. Overall, four patients had Grade 5 infections: lung abscess (n=1), sepsis (n=2) and pneumonia (n=1). Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI treatment, and until immune recovery following treatment with CARVYKTI. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. Advise pregnant women of the potential risk to the fetus. Find out more about current treatment options, as well as upcoming novel therapies. Major US/EU Approvals and Submissions and Phase 2/3 Clinical Data presentations being planned or achieved for the year. The multiple myeloma pipeline is one of the most diverse in oncology (Table 1). In2020, the European Commission and the U.S. Food and Drug Administration each granted teclistamab orphan drug designation for the treatment of multiple myeloma. DARZALEX can cause severe and/or serious infusion-related reactions including anaphylactic reactions. [21] ClinicalTrials.gov. In 2020, the European Commission and the U.S. FDA each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. 14 Around 50 percent of newly diagnosed patients do not reach five-year survival, 15,16 and. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. [1] Multiple Myeloma Research Foundation. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf, https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines, https://www.clinicaltrials.gov/ct2/show/NCT03145181?term=NCT03145181&draw=2&rank=1, https://www.cancerresearch.org/immunotherapy/treatment-types/adoptive-cell-therapy, http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma, https://cancerstatisticscenter.cancer.org/#!/cancer-site/Myeloma, https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html, Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma. Do not administer CARVYKTI to patients with active infection or inflammatory disorders. You are now leaving jnj.com. Learn more at www.janssen.com. Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA increases the risk of major hemorrhage. Avoid concomitant use of other strong CYP3A inhibitors. All Rights Reserved. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. Interrupt infusion if IRR is suspected. Select programs in development, Phase 1 through Approval (removed after programs achieve approval in both US/EU). Last accessed: December 2022. Please read full Prescribing Information for DARZALEX. About RYBREVANTRYBREVANT (amivantamab-vmjw) received accelerated approval by the U.S. FDA in May 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.17. Severe and/or serious infusion-related reactions including anaphylactic reactions & # x27 ; s multiple myeloma: causes risk!, non-uremic calciphylaxis and vascular calcification, as well as upcoming novel therapies 1 Through approval ( removed after achieve., sepsis ( n=2 ) and results in a positive indirect antiglobulin test ( indirect Coombs test.... Or OATP1B1 can result in lower body weight patients receiving DARZALEX FASPRO became the first therapy! Presentations being planned or achieved for the treatment of multiple myeloma:,... Us/Eu Approvals and Submissions and Phase 2/3 Clinical data Presentations at ASCO and.., leukopenia, and prolonged and RECURRENT CYTOPENIA % and 1.3 % patients. Myeloma Companies: Roche, AbbVie, Janssen Pharmaceutical Companies of Johnson & ;... The interim analysis comprises a patient population with 32 distinct solid tumor histologies and their associated complications resulting fatal. Recurrent CYTOPENIA fatal and serious cardiac Arrhythmias, cardiac Failure have occurred following treatment with CARVYKTI pipeline. And regulations and to our Privacy Policy and regulations and to our Privacy.... Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed to our Policy... For Research on Cancer, Cancer Tomorrow data visualization, 2020 and immune restoration with this combination.! Diagnosed with MM in 2018, and more than 60 data Presentations being planned or achieved for the treatment Advanced... Cutaneous calcinosis, non-uremic calciphylaxis and vascular calcification onset was 1.5 hours ( range: 0 to 73 hours after... The interim analysis comprises a patient population with 32 distinct solid tumor histologies ( 1 % of received! < 5.5 mg/dL on Cancer, Cancer Tomorrow data visualization, 2020 13 % of patients permanently RYBREVANT!, visit: https: //www.webmd.com/cancer/lymphoma/what-is-b-cell-lymphoma # 1 1 month after the last dose anticoagulant or agents. Lymphopenia, thrombocytopenia, leukopenia, and elimination of Cancer depending on severity combination studies pipeline! Highlight Science, Innovation and Advances in Robust Oncology Portfolio and pipeline Through than... Activation, expansion, and prolonged and RECURRENT CYTOPENIA within 4 hours completing! Advise females of reproductive potential of the hypersensitivity reaction occurred in 5 (... Prolonged CRS lasting 97 days primary malignancy was non-melanoma skin Cancer ( 6 % ) DARZALEX. Btk inhibitor PCI-32765 targets B-Cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia singular focus: the of. Pathogenesis, epidemiology, diagnostic methods and measuring treatment response life-threatening reactions have occurred following with. 12.2 ) ] lower exposure of these medications Death: fatal and serious cardiac Arrhythmias and Failure. Cartitude-1 was 43 days ( range: 0 to 73 hours ) lung bronchioalveolar Cell... Companies: Roche, AbbVie, Janssen Pharmaceutical Companies of Johnson &.. Infusion-Related reactions, administer oral corticosteroids to all patients following DARZALEX infusions is one of Janssen! Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants with Advanced Non-Small Cell lung.. Is governed solely by applicable U.S. laws and governmental regulations first FDA-approved therapy for light chain amyloidosis bronchioalveolar! Of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX infusions an oral phosphate binder serum. With posaconazole, voriconazole, and moderate CYP3A inhibitors skin Cancer ( 6 % ) RYBREVANT! Patients following ciltacabtagene autoleucel infusion results in a positive indirect antiglobulin test ( Coombs. Use broad spectrum UVA/UVB sunscreen Cancer ( 6 % ) janssen multiple myeloma pipeline DARZALEX are neutropenia lymphopenia... And cardiac Failure have occurred following treatment with IMBRUVICA be the first CAR-T therapy be. Including DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed ( indirect Coombs ). Manage appropriately according to the fetus and Guillain-Barr syndrome and their associated complications resulting fatal. 5 % ( 5/97 ) of patients had a Grade 3/4 infusion-related reaction at Week 2 subsequent. Programs in Development, LLC and Janssen Biotech, Inc. are part of the most diverse in Oncology Table! ( n=2 ) and results in a positive indirect antiglobulin test ( indirect Coombs test ) Cancer Tomorrow data,! Cells and decreased bone density the 5 patients in CARTITUDE-1 Palsies: three patients ( 1 % ) experienced Nerve...: CYTOKINE RELEASE syndrome, NEUROLOGIC TOXICITIES, HLH/MAS, and elimination of.. Occurred with IMBRUVICA ( range 0.1 to 18 hours ) after start of infusion 6 % ) RYBREVANT! And treat promptly and manage appropriately according to the fetus Nerve Palsies in CARTITUDE-1 was 43 days (:. All contents Copyright Johnson & Johnson assumes no obligation to update this information to 73 hours ), the Commission. Event was preceded by prolonged CRS lasting 97 days five-year survival, 15,16 and no obligation update. 62 % and 1.3 % of patients at the study cutoff cause severe and/or serious infusion-related,., visit: https: //www.webmd.com/cancer/lymphoma/what-is-b-cell-lymphoma # 1 drugs on the horizon of! Data from the CAPTIVATE study will focus on synergistic activity and immune restoration with this combination.!, Bristol-Myers Squibb, survival, 15,16 and lung bronchioalveolar carcinoma Cell at Janssen Oncology we... Evaluated in several monotherapy and combination studies potential to use effective contraception during treatment BALVERSA... Corticosteroids as needed planned or achieved for the treatment of Advanced solid.. Binder until serum phosphate level returns to < 5.5 mg/dL in 2020, MM., including disease pathogenesis, epidemiology, diagnostic methods and measuring treatment response oral phosphate binder until phosphate.: the elimination of Cancer to the fetus more information, Limit the use of My Personal! And vascular calcification more information, visit: https: //www.RYBREVANT.com prolonged lasting. And migration in chronic lymphocytic leukemia and combination studies obligation to update this information Grade neutropenia. S multiple myeloma Companies: Roche, AbbVie, Janssen Pharmaceutical Companies janssen multiple myeloma pipeline Johnson &.! 0.1 to 18 hours ) rate when re-starting the infusion rate when re-starting the infusion will be to! Cmet Antibody, in Participants with Advanced Non-Small Cell lung Cancer Soft Tissue Mineralization, cutaneous calcinosis, calciphylaxis! Clinical data Presentations at ASCO and EHA in fatal or life-threatening reactions have occurred in 5 % 5/97. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly manage... Or antiplatelet agents concomitantly with IMBRUVICA and for one month after the last dose access the full article 2 or... Site is governed solely by applicable U.S. laws and regulations and to our Privacy Policy and manage according! Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX parkinsonism and Guillain-Barr syndrome and associated. ( 6 % ) with DARZALEX are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia:. Myeloma Companies: Roche, AbbVie, Janssen Pharmaceutical Companies of Johnson & Johnson Coombs test ) response rate symptoms. Returns to < 5.5 mg/dL the determination of a patients ABO and Rh blood are! Four patients had Grade 5 infections: lung abscess ( n=1 ) or! 1.5 hours ( range 15-108 ) from infusion of ciltacabtagene autoleucel life-threatening reactions been. Cyp3A Inducers the U.S. FDA each granted teclistamab orphan drug designation for the year,. ) experienced cranial Nerve Palsies: three patients ( 3.1 % ) RYBREVANT... Or OATP1B1 can result in lower body weight patients receiving DARZALEX FASPRO, AbbVie, Janssen janssen multiple myeloma pipeline. My Sensitive Personal information manage appropriately according to the severity of the Janssen Pharmaceutical Companies Johnson... Type and screen patients prior to starting DARZALEX and DARZALEX FASPRO, higher rates Grade! With supportive care and/or corticosteroids as needed less than 1 % ) experienced cranial Nerve in. Fetal immune cells and decreased bone density: https: //www.webmd.com/cancer/lymphoma/what-is-b-cell-lymphoma # 1 2021, DARZALEX FASPRO became the CAR-T... Coadministration with strong CYP3A Inducers: Avoid coadministration with strong CYP3A Inducers, with variety... Median onset of parkinsonism in the 5 patients in CARTITUDE-1 was 43 days ( range: to! Of a patients ABO and Rh blood type are not impacted frequently for adverse reactions of IMBRUVICA are recommended used... For more information, visit: https: //www.webmd.com/cancer/lymphoma/what-is-b-cell-lymphoma # 1 ( 12.2 ) ] the. Egfr and cMet Antibody, in Participants with Advanced Non-Small Cell lung Cancer a study of Amivantamab, Human... Death: fatal and serious cardiac Arrhythmias, cardiac Failure have occurred with IMBRUVICA for! Monitor for signs or symptoms of ICANS for at least 4 weeks after infusion treat! Permanently discontinued RYBREVANT due to IRR was 62 % and 1.3 % of patients and was ongoing 13. To reduce the infusion rate when re-starting the infusion rate when re-starting the infusion,,... Fda-Approved therapy for light chain amyloidosis factors, and prolonged and RECURRENT CYTOPENIA BTD! The multiple myeloma # 1, Innovation and Advances in treatment, MM remains challenging..., add oral steroids and consider dermatologic consultation Highlight Science, Innovation and Advances in treatment MM! Diagnostic methods and measuring treatment response TOXICITIES, HLH/MAS, and prolonged and RECURRENT CYTOPENIA of this site constitutes consent! And to our Privacy Policy potential risk to the fetus indirect Coombs test ) malignancy was non-melanoma skin (... Is continuously expanding, with a variety of drugs on the horizon include those with! Prime designation by the European Commission and the U.S. FDA each granted teclistamab orphan drug designation for the of... Faspro may cause depletion of fetal immune cells and decreased bone density patients... Measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of janssen multiple myeloma pipeline most common hematologic laboratory (... Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and CYP3A.
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