Pfizer’s Elrexfio Receives the US FDA’s Accelerated Approval for Relapsed or Refractory Multiple Myeloma
Shots:
- The US FDA has granted accelerated approval to Elrexfio for r/r MM who have received 4 prior lines of therapy, incl. a proteasome inhibitor, an immunomodulatory agent & anti-CD38 mAb
- The approval was based on the P-II trial (MagnetisMM-3) evaluating Elrexfio in 187 patients. The cohort A of the P-II study results showed the responses in heavily pretreated patients who received Elrexfio as 1st BCMA-directed therapy, ORR (58%), 82% maintain response for 9mos., the median time to first response was 1.2mos. in patients who received ≥4 lines of therapy before Elrexfio
- The cohort B results were also included on the label which showed ORR (33%) after a median follow-up of 10.2mos., 84% maintain response for 9mos. in 63 patients who received four prior lines of therapy, incl. a BCMA-directed therapy
Ref: Pfizer | Image: Pfizer
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