The U.S. Food and Drug Administration on Thursday approved Johnson & Johnson’s (JNJ) antibody therapy Tecvayli (teclistamab) as part of a combination regimen for multiple myeloma, a type of blood cancer.
Specifically, the FDA has greenlighted Tecvayli with Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma who have already received at least one line of therapy previously.
Darzalex Faspro is a subcutaneous injection developed using Halozyme’s (HALO) Enhanze drug delivery technology.
The decision marks the third drug approval under the FDA Commissioner’s National Priority Voucher pilot program, which was launched last year to expedite the review of experimental therapies developed by companies aligned with U.S. national interests.
The FDA stated that the approval came in just 55 days after J&J (JNJ) received a national priority voucher for its marketing application for the drug combo in December.