On June 29, 2022, the FDA granted the investigational first-in-class anti-CD3 and anti-GPRC5D bispecific humanized monoclonal antibody talquetamab (Janssen) a breakthrough therapy designation for relapsed or refractory multiple myeloma in patients who have received ≥4 previous lines of therapy, including a proteosome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. In May 2021, the FDA granted talquetamab an orphan drug designation for the treatment of multiple myeloma.
“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,” said Sen Zhuang, MD, PhD, Vice President, Clinical Research and Development, Janssen Research and Development, in a press release. “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.”
This approval was based on the results of the phase 1/2 MonumenTAL-1 study, a first-in-human dose-escalation clinical trial that enrolled heavily pretreated patients with relapsed or refractory multiple myeloma. Talquetamab is currently being evaluated for the treatment of relapsed or refractory multiple myeloma, as well as in combination with the investigational T-cell redirecting bispecific antibody targeting B-cell maturation antigen teclistamab, for the treatment of relapsed or refractory multiple myeloma.