Janssen Pharmaceutical Companies, affiliated to drug major Johnson & Johnson (JNJ), announced Thursday that the U.S. Food and Drug Administration has granted accelerated approval of TALVEY (talquetamab-tgvs) for the treatment of patients with heavily pretreated multiple myeloma.
TALVEY is a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. These include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
The company noted that this indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).
The approval was based on the talquetamab Phase 2 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 trial showed meaningful overall response rates.
The TALVEY is the company's fifth innovative therapy and second bispecific antibody approved for the treatment of multiple myeloma.
TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy or REMS.
Ajai Chari, Director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco, said, "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. 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."
In pre-market activity on the NYSE, JNJ shares were trading at $173.80, up 0.42 percent.
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