EU approves Darzalex + Velcade + Thalomid + dexamethasone in newly diagnosed multiple myeloma.- Genmab
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The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the FDA seeking approval of JNJ 64007957 (teclistamab) for the treatment of patients with relapsed or refractory (R/R) multiple myeloma.
Amgen announced that the FDA has approved the expansion of the Kyprolis (carfilzomib) U.S. prescribing information to include its use in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022 for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA).