FDA Receives BLA for Talquetamab in Relapsed/Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) received a Biologics License Application (BLA) for the use of talquetamab in patients with relapsed or refractory multiple myeloma.

Talquetamab is an investigational, off-the-shelf, bispecific T-cell engager antibody targeting GPRC5D and CD3. It previously received Breakthrough Therapy designation from the FDA in June 2022 for the treatment of adults with relapsed or refractory multiple myeloma who underwent at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

“Despite the therapies that have been developed for the treatment of multiple myeloma, there remains persistent unmet needs for patients who relapse or become refractory,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head of Oncology at Janssen Research and  Development, in a statement.

The BLA is supported by data from the phase I/II, first-in-human MonumenTAL-1 study of talquetamab in patients with relapsed or refractory multiple myeloma who received more than three prior lines of therapy, Janssen officials said in a news release. Ajai Chari, MD, of Mount Sinai School of Medicine, and colleagues presented the phase II results of the MonumenTAL-1 study during the 2022 American Society of Hematology Annual Meeting and Exposition.

Talquetamab remains under evaluation in the phase I/II MonumenTAL-1 trial, as well as in the combination studies RedirecTT-1, TRIMM-2, TRIMM-3, MonumenTAL-2, and MonumenTAL-3.

The bispecific T-cell engager antibody received orphan drug designation for multiple myeloma from the FDA in May 2021. Talquetamab also received orphan drug designation from the European Commission in August 2021 after receiving a PRIME designation from the commission in January 2021.

Source: Janssen press release, December 2022