Talvey Gets Accelerated Approval for Myeloma Treatment
The FDA granted an accelerated approval for Talvey to treat patients with relapsed/refractory multiple myeloma.
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The FDA granted an accelerated approval for Talvey to treat patients with relapsed/refractory multiple myeloma.
/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted...
(Reuters) -Johnson & Johnson said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients with a difficult-to-treat type of blood cancer. The therapy, Talvey, belongs to a class of treatments called bispecific antibodies designed to bring a cancer cell and an immune cell together so the body's immune system can kill the cancer. Talvey will be sold at a list price of $45,000 per month, the company told Reuters, adding the price could vary based on a
Talquetamab-tgvs (Talvey) is a first-in-class bispecific antibody that binds to GPRC5D and CD3 to induce T cell-mediated killing of GPRC5D-expressing multiple myeloma cells.
The therapy's approval comes with FDA's "boxed" safety warning, flagging the risk of a type of aggressive immune response and neurologic toxicity.