Allogene Therapeutics (NASDAQ:ALLO) has announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its ALLO-316 for treating adult patients with CD70-positive advanced or metastatic renal cell carcinoma (RCC).
The RMAT designation was based on clinical data from Allogene’s ongoing Phase 1 TRAVERSE trial, which indicates ALLO-316’s potential to address the unmet needs of patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy. ALLO-316 also received Fast Track Designation from the FDA in March 2022.
“The RMAT designation for ALLO-316 highlights the transformative potential of our AlloCAR T platform to offer new hope for heavily pretreated patients with renal cell carcinoma who have exhausted standard treatment options,” said Zachary Roberts, M.D., Ph.D., executive vice president of research and development and CMO of Allogene. “This important milestone moves us closer to fulfilling the promise of “off-the-shelf” CAR T therapy—delivering faster, more reliable, and widely accessible treatments. We remain optimistic about the future of ALLO-316 and its potential to be an important advancement for patients.”
