The US Food and Drug Administration selected the supplemental Biologics License Application for teclistamab (TECVAYLI) plus daratumumab and hyaluronidase-fihj (DARZALEX FASPRO) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program.
The sBLA is based on phase 3 MajesTEC-3 results showing statistically significant progression-free survival and overall survival advantage for the combination versus standard treatment in relapsed or refractory multiple myeloma, according to a press release by Johnson and Johnson, the manufacturer of teclistamab. The company also noted that the study’s results support the combination as a potential standard of care as early as the second line.
The FDA granted the combination therapy Breakthrough Therapy Designation and is reviewing the sBLA under the Real-Time Oncology Review program.
The results were simultaneously presented at the 67th American Society of Hematology Annual Meeting and published in The New England Journal of Medicine.
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