Web Exclusives

Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma

Yvette Florio Lane

FDA Approvals, News & Updates, In the News, Synovial Sarcoma

On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug Designation to the agent for the treatment of soft tissue sarcomas. [ Read More ]

FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer

Yvette Florio Lane

Bladder Cancer, FDA Approvals, News & Updates, Immunotherapy

On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda). If approved, the drug would be indicated as monotherapy to treat patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non–muscle-invasive bladder cancer who are ineligible for or have decided not to undergo cystectomy. [ Read More ]