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Teclistamab Receives Accelerated Approval for Relapsed/Refractory Multiple Myeloma

The FDA has granted accelerated approval to teclistamab-cqyv (Tecvayli®, Janssen Biotech) for adult patients with relapsed/refractory multiple myeloma previously treated with four or more lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Teclistimab is the first bispecific B-cell maturation antigen (BCMA)–directed CD3 T-cell engager. "Standard treatment of multiple myeloma includes the administration of immunomodulatory agents, p...

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FDA Approves Daratumumab Plus Hyaluronidase-Fihj, Carfilzomib, and Dexamethasone for Multiple Myeloma

The FDA has approved daratumumab plus hyaluronidase-fihj (Darlazex Faspro®, Janssen Biotech) in combination with carfilzomib (Kyprolis®, Amgen) plus dexamethasone for patients with relapsed/refractory multiple myeloma who had received 1 to 3 prior lines of therapy. "Daratumumab is a human immunoglobulin G kappa monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action," wrote Ajai Chari, MD, Professor of Medicine, Hematology, and Medical Oncology at ...

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Isatuximab-Irfc Combination Approved for Multiple Myeloma

The FDA has approved isatuximab-irfc (Sarclisa®, Sanofi) in combination with carfilzomib and dexamethasone (Kd), for adult patients with relapsed or refractory multiple myeloma who have previously received one to three lines of therapy. "Treatment of relapsed/refractory multiple myeloma (RRMM) has greatly improved, yet relapse is inevitable and additional effective treatments are needed," wrote Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes in France,...

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