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# Janssen Files BLA for Myeloma Therapy
- URL: https://www.fdaweb.com/janssen-files-bla-for-myeloma-therapy/
- Published: 2022-12-09T12:00:00.000Z
- Updated: 2026-09-14T18:09:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153366

Janssen Pharmaceutical has submitted a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma. The bispecific T-cell engager antibody is designed to target both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and CD3 on T cells, according to the company.

The submission is based on data from the Phase ½ MonumenTAL-1 study ([Phase 1: NCT03399799](https://c212.net/c/link/?t=0&l=en&o=3732718-1&h=728330944&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03399799&a=Phase+1%3A+NCT03399799&ref=fdaweb.com); [Phase 2: NCT04634552](https://c212.net/c/link/?t=0&l=en&o=3732718-1&h=792937356&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04634552&a=Phase+2%3A+NCT04634552&ref=fdaweb.com)) in patients with relapsed or refractory multiple myeloma who have received more than three prior lines of therapy. The company says the Phase 2 results will be presented at the American Society of Hematology Annual Meeting 12/10.

FDA granted a breakthrough therapy designation in June, and an orphan drug designation 5/2021.