> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Biologic for Some Myelomas
- URL: https://www.fdaweb.com/fda-approves-biologic-for-some-myelomas/
- Published: 2022-10-25T12:00:00.000Z
- Updated: 2026-09-14T18:04:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153050

FDA has given accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech), described as the first bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myelomas who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. An agency [statement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma?ref=fdaweb.com) says teclistamab-cqyv was evaluated in MajesTEC-1 with the main outcome measure being overall response rate as determined by an Independent Review Committee assessment using an international working group criteria.

The drug’s labeling includes a Boxed Warning for life-threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity. Because of these risks, it is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.

The most common adverse reactions in the trial were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.

The FDA review was conducted under Project Orbis with regulatory agencies in Australia, Brazil, Canada, and Switzerland. The review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. The application was granted priority review and breakthrough designation and also was granted orphan drug designation.