Talvey, a bispecific therapy, indicated for the treatment of patients with relapsed, refractory, heavily pretreated multiple myeloma<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b><\/p>\n
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TUESDAY, Aug. 15, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Talvey<\/a> (talquetamab-tvgs) for patients with relapsed or refractory multiple myeloma.<\/p>\n The accelerated approval is for individuals who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talvey is a bispecific antibody targeting CD3 on T cells and G protein-coupled receptor class C group 5 member D, expressed on the surface of multiple myeloma cells.<\/p>\n Findings from the phase 2 MonumenTAL-1 study showed both a positive response rate and durability of response. At a biweekly dose of 0.8 mg\/kg, 73.6 percent of patients achieved an overall response rate. Over a median of six months from first response among responders, 58 percent of patients achieved a very good partial response or better, including 33 percent of patients achieving a complete response or better. For a weekly dose of 0.4 mg\/kg, 73.0 percent of patients achieved an overall response rate, and over a median of nearly 14 months from first response among responders, 57 percent of patients achieved a very good partial response or better, including 35 percent of patients achieving a complete response or better. In the 0.8 mg\/kg biweekly dose group, an estimated 85 percent of responders maintained response for at least nine months.<\/p>\n The most common nonhematologic adverse effects were oral toxicities (80 percent of patients), weight loss (62 percent), and serious infections (16 percent).<\/p>\n Approval of Talvey was granted to Janssen.<\/p>\n