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FDA Alerts
Oncology

FDA approves Tecvayli for previously treated relapsed/refractory multiple myeloma

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The U.S. Food and Drug Administration has approved teclistamab-cqyv (Tecvayli) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received ≥4 prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate.

In the pivotal Phase 2 MajesTEC-1 clinical trial including patients who had received a median of 5 prior lines of therapy (n = 110), there was an overall response rate of 61.8%, with 28.2% of patients achieving a complete response (CR) or better (CR or stringent complete response).The median time to first response was 1.2 months (range 0.2 to 5.5 months). With a median follow-up of 7.4 months, the estimated duration of response rate was 90.6% at 6 months and 66.5% 9 months.

“Today’s achievement, which marks an important addition to our diverse and growing oncology portfolio, strengthens our resolve to discover and develop much-needed cancer treatments for patients and physicians,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC, in a press release. “The approval of Tecvayli, which demonstrated an overall response rate of more than 60 percent in heavily pretreated patients, underscores our commitment to translate science into medicines as we strive toward our goal of one day eliminating this disease.”

Read the full press release here.

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