The FDA has issued a supplemental biologics license application to teclistamab, a Johnson & Johnson therapy, to participate in its National Priority Voucher pilot program, according to Dec. 15 news releases from the agency and the company.
The application is based on data from the phase 3 Majestec-3 trial evaluating teclistamab (Tecvayli) in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) in patients with relapsed or refractory multiple myeloma. The combination showed statistically significant improvements in progression-free and overall survival compared to standard treatment after three years.
The FDA granted the regimen a breakthrough therapy designation and is reviewing the application through its Real-Time Oncology Review program. It also awarded the combination a priority voucher under the pilot, which allows for expedited application review and enhanced regulatory communication.
The trial results were presented as a late-breaking oral abstract at the American Society of Hematology Annual Meeting and simultaneously published in The New England Journal of Medicine.
Teclistamab is the 16th recipient of a voucher since the program launched in October. Earlier recipients include therapies for Type 1 diabetes, congenital deafness, sickle cell disease, and obesity. Six products were added Nov. 6, bringing the total to 15 before the latest award.
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