USFDA Approves Johnson and Johnson's Blood Cancer Drug Tecvayli-Darzalex Combo via Fast-Track Voucher Program
Bengaluru: The U.S. Food and Drug Administration on Thursday approved Johnson & Johnson's treatment for a type of blood cancer, making it the third drug cleared under the agency's new speedy review program.
The health regulator approved the use of Tecvayli in combination with Johnson & Johnson's Darzalex in patients with multiple myeloma who have received at least one prior line of therapy.
This was one of the 18 drugs selected so far for the FDA Commissioner's National Priority Voucher Program that allows a speedy process and cuts the review time to one to two months from the typical 10 to 12 months.
The decision was issued 55 days after filing, the agency said.
In a late-stage trial, the combo showed significant improvement over the standard of care in patients. It reduced the risk of disease progression or death by 83% relative to the standard of care.
The health regulator's nod also converts the accelerated approval to traditional approval for Tecvayli as standalone treatment for those who have received at least four prior lines of therapy. It received accelerated approval for the indication in 2022.
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell.
