U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma

On March 6, 2026 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.1

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"The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme

The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. TECVAYLI in combination with DARZALEX FASPRO demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).2 The three-year PFS rate was 83%,2 underscoring a durable benefit.

For more information on this approval, please view Johnson & Johnson’s press release issued on March 5, 2026.

(Press release, Halozyme, MAR 6, 2026, View Source;FDA-Approves-TECVAYLI-in-Combination-with-DARZALEX-FASPRO-for-RelapsedRefractory-Multiple-Myeloma/default.aspx [SID1234663338])