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# Breakthrough Designation for Janssen’s Talquetamab
- URL: https://www.fdaweb.com/breakthrough-designation-for-janssens-talquetamab/
- Published: 2022-06-29T12:00:00.000Z
- Updated: 2026-09-14T17:50:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152192

FDA has granted breakthrough therapy designation for Janssen’s talquetamab to treat adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The company [describes](https://www.janssen.com/us/sites/www%5Fjanssen%5Fcom%5Fusa/files/janssen%5Fannounces%5Fus%5Ffda%5Fbreakthrough%5Ftherapy%5Fdesignation%5Fgranted%5Ffor%5Ftalquetamab%5Ffor%5Fthe%5Ftreatment%5Fof%5Frelapsed%5For%5Frefractory%5Fmultiple%5Fmyeloma.pdf?ref=fdaweb.com) talquetamab as an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D, a novel drug target, on multiple myeloma cells and CD3 on T-cells.

The breakthrough designation was supported by data from the Phase 1/2, first-in-human dose-escalation MonumenTAL-1 study of talquetamab for treating heavily pretreated patients with relapsed or refractory multiple myeloma, Janssen says.