US biopharmaceutical company Halozyme Therapeutics Inc (NASDAQ:HALO) announced on Friday that Johnson & Johnson (J&J) (NYSE:JNJ) has received approval from the US 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.

The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomised 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 progression-free survival and overall survival in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results showed an 83% decrease in the risk of disease progression or death compared to standard regimens. The three-year PFS rate was 83%, highlighting 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.