FDA Selects Johnson & Johnson's Tecvayli Plus Darzalex Faspro for Priority Review in Multiple Myeloma
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The FDA has selected Johnson & Johnson's supplemental Biologics License Application for TECVAYLI® and DARZALEX FASPRO® for priority review under the Commissioner’s National Priority Voucher Pilot Program. This decision aims to expedite access to innovative therapies for relapsed/refractory multiple myeloma, based on positive Phase 3 trial results. The combination has also been granted Breakthrough Therapy Designation and is under Real-Time Oncology Review.
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