On 5 March 2026, J&J announced the US approval of Tecvayli® (teclistamab-cqyv) in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of relapsed or refractory multiple myeloma (RRMM) as a second line treatment.
This approval was based on the Phase 3 MajesTEC-3 study, which evaluated the safety and efficacy of teclistamab and daratumumab in RRMM patients who had received at least one prior line of therapy, against the one of the following combinations:
- daratumumab, dexamethasone and pomalidomide or
- daratumumab, dexamethasone, bortezomib
The Tecvayli®/Darzalex Faspro® combination demonstrated the best patient outcomes, showing an 83% reduction in the relative risk of progression or death when compared with standard treatment.
Approval was granted 55 days after filing, following the selection of the teclistamab’s sBLA under the Commissioner’s National Priority Voucher Pilot Program.
Daratumumab biosimilars are under development by Celltrion, Henlius, and CSPC. Globally, the first approval for a daratumumab biosimilar was granted in Russia to Biocad in August 2025. There is no evidence that any teclistamab biosimilars have been submitted for regulatory review or approval.