FDA grants accelerated approval of Janssen’s Talvey

The Janssen Pharmaceutical Companies of Johnson & Johnson announced earlier that the U.S. Food and Drug Administration has granted accelerated approval of Talvey, or talquetamab-tgvs, 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, 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. Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s),” the company noted.