The U.S. Food and Drug Administration (FDA) has given accelerated approval to teclistamab-cqyv (Tecvayli) to treat adults with with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Teclistimab is a bispecific T-cell engager antibody that is administered as a subcutaneous treatment.

The approval was largely based on the MajesTEC-1 clinical trial, (NCT04557098NCT03145181),  a phase  1/2 study. In the phase 2 portion of the study, 110 patients who had received a median of five prior lines of therapy were given teclistamab (1.5 mg/k).  An overall response rate (ORR) of 61.8% was achieved with 28.2% of patients obtaining a complete response or stringent complete response. The median time to first response was 1.2 months and the estimated duration of response (DOR) rate was 90.6 % at six months and 66.5%  at nine months. (median follow-up was 7.6 months in the study).

The accelerated approval was based on the exceptional response rates observed – a significant achievement given the high level of previous treatments these patients had undergone. Continued approval for this indication will likely be dependent upon verification and description of clinical benefit in confirmatory trial(s).

Earlier this year, we talked to Ajay K. Nooka, MD, Associate Professor of Hematology and Medical Oncology at Emory School of Medicine, about the MajesTEC-1 study and the data presented at ASCO 2022.


In a news release following the drug approval, Dr. Chari stated, “As a clinician and researcher, I see first-hand the human toll of this incurable disease. The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many of these hard-to-treat patients.”

To stay up-to-date on the latest FDA approvals, go to 2022 Orphan Drugs: PDUFA Dates and FDA Approvals.