sBLA for Tecvayli OK’d for Reduced Dosing

FDA has approved a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR). The therapy was originally approved 10/22 for treating adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

The sBLA approval is based on data from the Phase 1/2 MajesTEC-1 study (Phase 1: NCT03145181; Phase 2: NCT04557098) in patients initially treated with the recommended Phase 2 dose of 1.5 mg/kg weekly, according to the company. “Patients who achieved a confirmed CR or better for six months or longer (Phase 2), were eligible to reduce dosing frequency to 1.5 mg/kg [every two weeks] until disease progression or unacceptable toxicity,” it says.