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# sBLA for Tecvayli OK’d for Reduced Dosing
- URL: https://www.fdaweb.com/sbla-for-tecvayli-okd-for-reduced-dosing/
- Published: 2024-02-21T12:00:00.000Z
- Updated: 2026-09-14T14:23:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156403

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](https://c212.net/c/link/?t=0&l=en&o=4096188-1&h=3410975175&u=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT03145181&a=Phase+1%3A+NCT03145181&ref=fdaweb.com); [Phase 2: NCT04557098](https://c212.net/c/link/?t=0&l=en&o=4096188-1&h=2433166369&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04557098&a=Phase+2%3A+NCT04557098&ref=fdaweb.com)) 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.