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FDA Approves Daratumumab Triplets for Relapsed Myeloma

Jason M. Broderick @jasoncology
Published: Monday, Nov 21, 2016

Jan van de Winkel, PhD

Jan van de Winkel, PhD

The FDA has approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy, based on findings from the phase III POLLUX and CASTOR studies.1,2

The FDA is also reviewing an application for the combination of daratumumab, pomalidomide (Pomalyst), and dexamethasone in patients with relapsed or refractory multiple myeloma following at least 2 prior therapies, with a proteasome inhibitor and an IMiD. A decision for this indication is anticipated by June 17, 2017.
References
  1. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331.
  2. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-766.

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