5/12/2024 0 Comments Adcs ema loginSystemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.Classical HL at high risk of relapse or progression as post auto-HSCT consolidation treatment.Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.The drug is also approved for the treatment of patients with: Food and Drug Administration for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma ( pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body). ![]() Hodgkin lymphoma, systemic anaplastic large cell lymphomaīrentuximab vedotin (Adcetris® Seattle Genetics) is approved by the U.S. * In November 2022, after an update from the phase 3 DREAMM-3 study the use of belantamab monotherapy for previously treated patients with relapsed or refractory multiple myeloma was pulled from US market authorization by request of the US Food and Drug Administration (FDA). Access & reimbursement enrollment form (United States Only).Blenrep REMS (Risk Evaluation and Mitigation Strategy).The recommended dosage is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks (Q3W). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). This indication is approved under accelerated approval based on the response rate. Developed disease recurrence during or within six months of completing adjuvant therapyīelantamab mafodotin-blmf (Blenrep™ GSK) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.Received prior therapy for metastatic disease, or.healthcare professional, do not continue on this page.Īdo-trastuzumab emtansine (Kadcyla® Genentech/Roche), as a single agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. Food and Drug Administration (FDA) and intended for U.S. The information on this page is limited to commercially available antibody-drug conjugates approved by the U.S.
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