US FDA Grants Third Approval Under the National Priority Voucher Program
United States, March 6 -- The U.S. Food and Drug Administration approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This decision, which was issued 55 days after filing, marks the third approval under the new Commissioner's National Priority Voucher (CNPV) pilot program. The FDA proactively awarded a voucher for the drug combination on December 15, 2025, after FDA leaders learned about a Phase 3 clinical trial study in which Tec-Dara showed significant improvements over the standard of care in both progression-free survival and overall survival. Notably, in that study, Tec-Dara reduced the...
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