Tecelra treats rare cancer through immunotherapy.
The U.S. Food and Drug Administration (FDA) has approved Tecelra (afamitresgene autoleucel), a gene therapy for adults with unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy. Synovial sarcoma is a rare cancer that affects about 1,000 people annually in the U.S., mostly males in their 30s or younger.
“The approval of this state-of-the-art immunotherapy technology provides a critical new option for a patient population in need and demonstrates the FDA’s dedication to the advancement of beneficial cancer treatments,” said the FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks.
Approved via the Accelerated Approval pathway, Tecelra has received Orphan Drug, Regenerative Medicine Advanced Therapy, and Priority Review designations, with ongoing trials to confirm its clinical benefits. The FDA granted approval to Adaptimmune, LLC, after a cross-agency review process.
As the Lord Leads, Pray with Us…
- For Director Marks to be discerning as he heads the FDA’s Center for Biologics Evaluation and Research.
- For Commissioner Robert Califf to be led by the Lord as he heads the FDA.
Sources: Food and Drug Administration
