FDA Reviews Johnson & Johnson's TECVAYLI and DARZALEX FASPRO Combination for Multiple Myeloma

Reuters12-09
FDA Reviews Johnson & Johnson's TECVAYLI and DARZALEX FASPRO Combination for Multiple Myeloma

Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the combination of TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a treatment for relapsed/refractory multiple myeloma (RRMM). The FDA has granted Breakthrough Therapy Designation for the combination regimen, expediting its development and review. The sBLA is being reviewed through the Real-Time Oncology Review (RTOR) program. Additionally, an application has been submitted to Brazil's health agency, ANVISA.

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