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Continued approval to be based on verification and description of clinical benefit in confirmatory trials.
Janssen Pharmaceuticals, a wholly owned subsidiary of Johnson & Johnson (J&J), announced the FDA approval of Talvey (talquetamab-tgvs). Indicated for the treatment of patients with heavily pretreated multiple myeloma, the medication was approved as a result of an overall positive response rate and durability of response.
“The approval of Talvey, our fifth innovative therapy and second bispecific antibody approved for the treatment of multiple myeloma, demonstrates our commitment to expanding our portfolio of medicines to help address unmet needs for patients who continue to face challenges with this complex hematologic malignancy,” said Peter Lebowitz, MD, PhD, global therapeutic area head, oncology, Janssen Research & Development, LLC, in a company press release. “Our team of scientists never settles in their determination to discover and develop effective therapies. With the discovery of this new antigen, we continue to strive for research breakthroughs while remaining focused on delivering curative regimens in our commitment to eliminate cancer.”
Reference: U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma. Johnson & Johnson. August 10, 2023. Accessed August 11, 2023. https://www.jnj.com/u-s-fda-approves-talvey-talquetamab-tgvs-a-first-in-class-bispecific-therapy-for-the-treatment-of-patients-with-heavily-pretreated-multiple-myeloma