A combination of Johnson & Johnson’s (JNJ) Tecvayli (teclistamab) and Darzalex (daratumumab) for multiple myeloma has been granted a national priority voucher under an FDA Commissioner pilot program.
The pilot allows faster review — typically one to two months — for treatments seen as addressing an unmet medical need, promoting domestic drug development and manufacturing, or strengthen US supply chain resiliency.
The J&J combo is the 16th therapy to receive the designation.
Recent phase 3 data on Tec-Dara showed improvements in progression-free survival and overall survival in patients who failed one to three prior therapies. At three years, more than 80% of those on the combo remained progression free.
