Janssen Pharma gets USFDA Breakthrough Therapy Designation for Multiple Myeloma treatment Talquetamab
Talquetamab is 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.
Raritan, N.J.: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the U.S. Food and Drug Administration (USFDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Talquetamab is 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.
This distinction for talquetamab follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) on January 29, 2021, and an Orphan Drug Designation (ODD) from the FDA on May 3, 2021.
"This Breakthrough Therapy Designation marks an important step in the continued development of talquetamab, a first-in-class bispecific antibody T-cell engager using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma," said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. "Despite the therapies available for patients with relapsed or refractory multiple myeloma, new targets and treatments are needed because of the heterogeneity of the disease, which can impact a patient's response to treatment. We are resolute in our commitment to advance science and develop new therapies and regimens for patients with the goal of delivering the best possible outcomes while driving toward cures."
The Breakthrough Therapy Designation is supported by data from the Phase 1/2, first-in-human dose-escalation MonumenTAL-1 study of talquetamab (Phase 1: NCT03399799; Phase 2: NCT04634552) for the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma.
Data from the MonumenTAL-1 study were featured during the 2022 European Hematology Association (EHA) Annual Congress as an oral presentation and were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement in at least one clinically significant endpoint over available therapy.
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