J&J seeks approval of Darzalex for early-stage multiple myeloma
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- Johnson & Johnson (NYSE:JNJ) has submitted applications to drug regulators in the U.S. and EU seeking approval of, respectively, Darzalex Faspro (daratumumab and hyaluronidase-fihj) and Darzalex (daratumumab) for a type of early-stage multiple myeloma.
- The healthcare giant is seeking approval of the drugs for smoldering MM at high-risk of developing to active forms of the disease.
- The applications are supported by data from the phase 3 Aquila trial, results of which were just presented and which found that the primary endpoint, progression-free survival, was met.