Johnson & Johnson said the U.S. Food and Drug Administration approved TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The company said the approval was based on Phase 3 MajesTEC-3 data and noted the application received Breakthrough Therapy Designation and Real-Time Oncology Review and was included in the FDA Commissioner’s National Priority Voucher Pilot Program.

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