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Japan Approves Daratumumab for Relapsed/Refractory Myeloma

Jason Harris
Published: Tuesday, Oct 03, 2017

Jan van de Winkel, PhD
Jan van de Winkel, PhD
The Japanese Ministry of Health, Labor and Welfare has approved the use of daratumumab (Darzalex) for the treatment of adults with relapsed/refractory multiple myeloma.

In the CASTOR study, the most common grade 3/4 AEs were thrombocytopenia (45.3% in the daratumumab group vs 32.9% in the control), anemia (14.4% vs 16.0%), and neutropenia (12.8% vs 4.2%). Daratumumab-associated infusion-related reactions were reported in 45.3% of patients. These were mostly grade 1/2, and occurred predominantly during the first infusion.

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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