Liver enzyme elevation can occur with or without concurrent CRS. Swallow IMBRUVICA capsules or tablets whole with a glass of water. 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). Do not cut, crush, or chew IMBRUVICA tablets. American Cancer Society. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. Take IMBRUVICA exactly as your healthcare provider tells you to take it. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-cancer-related-fatigue.html. The MCL and MZL indications are approved under accelerated approval based on overall response rate. Hypertension: Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA in clinical trials. The MCL and MZL indications are approved under accelerated approval based on overall response rate. 24. Pharmaceutical Companies. CYP3A Inhibitors:Co-administration of IMBRUVICA with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.4.2021. 31. 24 ClinicalTrials.gov Identifier: NCT04991753. Based in San Diego, California, Scripps Conference Services and CME is committed to improving the quality of health care and advancing the practice of medicine by providing evidence-based, up-to-date and clinically relevant continuing medical education (CME) courses. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated. DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO-treated patients with IgG kappa myeloma protein. The authorized source of trusted medical research and education for the Chinese-language medical community. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). The clinical usefulness of PD-L1 as a biomarker in advanced urothelial carcinoma is an area of uncertainty. DARZALEX FASPRO may cause depletion of fetal immune cells and decreased bone density. All the authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol and the statistical analysis plan. ); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K. In the PD-L1positive population, the median progression-free survival was 5.7 months (95% CI, 3.7 to 7.4) in the avelumab group and 2.1 months (95% CI, 1.9 to 3.5) in the control group (stratified hazard ratio, 0.56; 95% CI, 0.43 to 0.73) (Figure 2B). Talquetamab was also granted Breakthrough Therapy Designation from the U.S. FDA in June 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. CARVYKTI REMS: Because of the risk of CRS and neurologic toxicities, CARVYKTI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI REMS. Percentages may not total 100 because of rounding. Denman et al previously demonstrated a method of NK cell expansion using membrane-bound interleukin-21 (mbIL-21)expressing feeder cells and IL-2. Zajac M, Boothman A-M, Ben Y, et al. 2014;6:4782. For more information, visit www.CARVYKTI.com. Do not cut, crush or chew IMBRUVICA tablets. 26. You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA. Neurologic Toxicity including ICANS - TECVAYLI can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Popular FAQ. Monitor complete blood counts monthly. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA. Patients who experienced peripheral neuropathy also experienced cranial nerve palsies or GBS in other ongoing trials of ciltacabtagene autoleucel. All three patients had 7th cranial nerve palsy; one patient had 5th cranial nerve palsy as well. WARNINGS AND PRECAUTIONSInfusion-Related ReactionsDARZALEX can cause severe and/or serious infusion-related reactions including anaphylactic reactions. This information is intended for use by our customers, patients, and healthcare professionals in the United States and Puerto Rico only. Please see full Prescribing Information for DARZALEX FASPRO. Reasons that the response could not be evaluated were the following: no evidence of disease at baseline (in 52 patients), no postbaseline assessments owing to other reasons (in 18), stable disease occurring less than 6 weeks after randomization (in 2), progressive disease occurring more than 12 weeks after randomization (in 2), no postbaseline assessments owing to early death (in 1), and new anticancer therapy started before the first postbaseline assessment (in 1). Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. The 2022 San Diego Day of Trauma are breastfeeding or plan to breastfeed. General information about the safe and effective use of IMBRUVICA. 5. 18 NK cells stimulated with this technique expand >10 000-fold over 21 days, which is far greater than using mbIL-15expressing feeder cells or IL-2 or IL-15 stimulation. The trial was conducted in accordance with the ethics principles of the Declaration of Helsinki and with the Good Clinical Practice guidelines defined by the International Council for Harmonisation. Responses in the Overall Population and the PD-L1Positive Population. In patients who received TECVAYLI at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. Do not cut, crush or chew IMBRUVICA tablets. IMBRUVICA is approved in more than 100 countries and has been used to treat more than 270,000 patients worldwide. WARNINGS AND PRECAUTIONSHypersensitivity and Other Administration ReactionsBoth systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO. Do not breastfeed during treatment with IMBRUVICA and for 1 week after the last dose. Data Supporting Janssen's Innovative Multiple Myeloma Pipeline and Portfolio More than 35 presentations will highlight data from a robust pipeline and portfolio addressing the heterogeneity of this disease. Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions. Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these contain strong or moderate inhibitors of CYP3A. LEARN MORE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. Lancet Oncol 2016;17:1590-1598. is a founder and equity holder of Volastra Therapeutics and OneThree Biotech; is a member of the scientific advisory boards of Owkin, Freenome, Genetic Intelligence, Acuamark, and Champions Oncology; and receives research support from Eli Lilly, Janssen, and Sanofi. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Monitor patients with cardiac involvement of light chain (AL) amyloidosis more frequently for cardiac adverse reactions and administer supportive care as appropriate. The most frequent category of immune-related adverse events was thyroid disorders, which occurred in 42 patients (12.2%). Exhibitor Karyopharm 11-6 . have had recent surgery or plan to have surgery. Bukhari N, Al-Shamsi HO, Azam F. Update on the treatment of metastatic urothelial carcinoma. Galsky MD, Arija JA, Bamias A, et al. Percentages may not total 100 because of rounding. Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Fatal HLH occurred in one patient (1%), 99 days after ciltacabtagene autoleucel. 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. Infections - TECVAYLI can cause severe, life-threatening, or fatal infections. J Clin Oncol 2019;37:Suppl:4503-4503. abstract. February 23, 2023, Originally broadcast October 22 & 23, 2021, 35th Annual New Treatments in Chronic Liver Disease, 15th Annual Brain Injury Rehabilitation Conference, Originally broadcast June 4th - 5th, 2021, Eighth Annual Clinical Advances in Heart Failure and Arrhythmias, Originally broadcast April 24th - 25th, 2021, Originally broadcast February 20 & 21, 2021, Originally broadcast November 6 & 7, 2020, 37th Annual Primary Care Summer Conference. 16. InAugust 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. Previously Treated Marginal Zone Lymphoma*. Exhibitor Janssen Pharmaceuticals 09-11. The most common hematologic laboratory abnormalities (40%) with DARZALEX are: neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia. We found that first-line maintenance avelumab therapy in patients with advanced urothelial carcinoma with disease that had not progressed with platinum-based chemotherapy resulted in significantly longer overall survival than best supportive care alone. Grivas P, Monk BJ, Petrylak D, et al. Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: results of a randomized phase 2 trial. The determination of a patient's ABO and Rh blood type is not impacted. IMPORTANT: CLICK HERE TO REVIEW RECENT IMPORTANT LABEL UPDATE. Interference With Determination of Complete ResponseDaratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Recurrent CRS occurred in 33% of patients. Cardiac Arrhythmias, Cardiac Failure, and Sudden Death:Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA. This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. Table 3. Between May 11, 2016, and June 4, 2019, a total of 700 patients were enrolled at 197 sites in 29 countries. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Permanently discontinue DARZALEX therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. Entwicklung und klinische Studien. IMBRUVICA comes as capsules, tablets, and oral suspension. Secondary end points included progression-free survival and safety. 4. 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