Johnson & Johnson reported Phase 3 data showing Darzalex Faspro plus Talvey, with or without Pomalyst, reduced risk of progression or death in earlier-line multiple myeloma. The company framed the readout as a potential path to expand Talvey’s label, supported by results published in The New England Journal of Medicine. After two years, Talvey plus Darzalex Faspro cut the risk of death by as much as 53% versus the standard regimen, and reduced risk of progression or death by up to 72% in the analysis. J&J said the dataset marks the first demonstration of superior progression-free survival with a GPRC5D bispecific combination in earlier-line settings. Regulatory strategy now shifts to coordinating with global health authorities on expanded use, with competitors watching whether the bispecific’s benefit can sustain beyond later lines and translate into clinically meaningful endpoints.
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