FDA Approves Tecvayli Plus Darzalex Faspro for Relapsed or Refractory Multiple Myeloma
- nuaxia
- 2 days ago
- 2 min read
Combination therapy demonstrates significant improvements in progression-free and overall survival in adults after at least one prior treatment, offering a new standard-of-care option.
The U.S. FDA has approved Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Approval is based on the Phase III MajesTEC-3 trial, which demonstrated significant improvements in progression-free survival, overall survival (83.3% vs 65% at 3 years), and response rates, with manageable safety and low discontinuation rates.
Alert Type | Drug Approval (FDA) |
Drug/Device Name | Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab and hyaluronidase-fihj) |
Indication | Treatment of adults with relapsed or refractory multiple myeloma (r/r MM) who have received at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent |
Therapy Area(s) | Haematology / Oncology |
Geography | US (FDA) |
What Changed | The FDA approved Tecvayli in combination with Darzalex Faspro for adults with r/r MM, based on the Phase III MajesTEC-3 trial showing significant improvements in progression-free survival, overall survival, and response rates compared to standard regimens. |
Clinical Relevance | Provides a new standard-of-care combination therapy for r/r MM, with robust efficacy (OS 83.3% vs 65% at 3 years) and manageable safety, expanding treatment options for patients after at least one prior therapy. |
Source Link | |
Date | 13-Feb-2026 |
Status | Draft |
Notes | Approval supported by ongoing Phase III MajesTEC-3 study; breakthrough therapy designation, Commissioner’s National Priority Voucher, and real-time oncology review; adverse events mainly cytopenias and infections, low discontinuation rates; cytokine release syndrome mostly Grade 1/2. |
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