On Thursday, the U.S. Food and Drug Administration approved Johnson & Johnson‘s (NYSE:JNJ) Tecvayli in combination with Darzalex Faspro for patients with relapsed or refractory multiple myeloma.

The agency also selected the teclistamab MajesTEC-3 supplemental Biologics License Application to participate in the Commissioner's National Priority Voucher pilot program.

Phase 3 Data

The decision was based on Phase 3 data showing significant improvements in survival. In the MajesTEC-3 study, 83.3% of patients receiving the therapy were alive at three years, indicating durable clinical benefit. Three-year progression-free survival in the control arm was 30%.

Tecvayli was first approved in 2022 for heavily pretreated multiple myeloma patients and received an expanded label in 2024 allowing reduced dosing frequency for those maintaining a complete response for at least six months.

The latest approval expands treatment options for patients with blood cancer.

Johnson & Johnson Technical Analysis

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