CNPV
March 5, 2026
FDA approves teclistamab and daratumumab from Johnson & Johnson under the Commissioner’s National Priority Voucher program
The FDA approved today teclistamab and daratumumab in combination from Johnson & Johnson for relapsed or refractory multiple myeloma under the Commissioner’s National Priority Voucher program.
This application was approved 55 days from filing (this application was also under real-time review so it is likely 55 days from the application being complete not when the submission was started).
- Oct 15, 2025: Positive top-line results
- Dec 9, 2025: Johnson & Johnson announced they have initiated the submission for the supplemental Biologics Licence Application (sBLA) submitted through the Real-Time Oncology Review program
- Dec 15, 2025: FDA awarded Commissioner's National Priority Voucher
- March 5, 2026: FDA approval of sBLA
