The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s TECVAYLI (teclistamab-cqyv) plus 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, including a proteasome inhibitor and an immunomodulatory agent.

TECVAYLI and DARZALEX FASPRO work synergistically to prime and activate the immune system to eradicate myeloma cells that express the BCMA protein. This approval offers a potential new standard of care (SOC) as early as second line and brings a novel treatment approach for patients with multiple myeloma who experience disease relapse.

“This approval represents another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings,” said Imran Khan, M.D., Ph.D., Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson. “The FDA approval of TECVAYLI plus DARZALEX FASPRO adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease.”

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). The three-year PFS rate was 83%, underscoring a durable benefit.

“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 CEO of Halozyme.