FDA approves J&J's BCMA-targeted bispecific for multiple myeloma
The FDA on Tuesday granted accelerated approval to Johnson & Johnson’s Tecvayli (teclistamab), a BCMA-directed bispecific antibody, looking to head into an already crowded field of treatments aiming to help those with the blood cancer multiple myeloma.
The approval, which included a REMS due the risks of CRS and neurologic toxicity, follows promising early efficacy in 40 patients, with 65% of patients having a partial response or better, and further data from a Phase I/II trial, published in the New England Journal of Medicine earlier this month, known as MajesTEC-1. Those results showed that in a larger group of 165 patients, with median follow-up of 14.1 months (range of 0.3 to 24.4), responses occurred in 104 patients (63%; 95% confidence interval [CI], 55.2 to 70.4), as well as a partial response or better in 97 patients (58.8%), and a complete response or better in 65 (39.4%).
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