The US Food and Drug Administration (FDA) has granted accelerated approval to talquetamab-tgvs (TALVEY) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
This indication is approved under accelerated approval based on response rate and durability of response, and continued approval for this indication is “contingent upon verification and description of clinical benefit in confirmatory trials,” according to a news release from Janssen Pharmaceutical Companies of Johnson & Johnson, the manufacturer.
Talquetamab-tgvs is a bispecific T-cell-engaging antibody that binds to CD3 and GPRC5D. It is approved as a weekly or biweekly subcutaneous injection after an initial step-up phase.
The bispecific antibody was evaluated in the MonumenTAL-1 study, which included patients who had received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy. The study also included 32 patients who were exposed to prior bispecific antibody or chimeric antigen receptor (CAR) T-cell therapy and had received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
“The clinically meaningful efficacy and safety profile observed with talquetamab in heavily pretreated patients in this clinical trial, which included patients treated with prior BCMA-targeted bispecific or CAR-T cell therapy, has been notable,” Ajai Chari, MD, Director of the Multiple Myeloma Program and Professor of Clinical Medicine at the University of California, San Francisco said in the news release. “Patients at this stage of disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.”
The safety profile includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome. Warnings and precautions include oral toxicity, weight loss, infections, cytopenias, skin toxicity, hepatoxicity and embryo-fetal toxicity, officials said in the news release.
Source: PR Newswire, August 2023