Celcuity reports positive Phase 3 data for gedatolisib, bolstering broader approval prospects

Celcuity announced new data from an ongoing Phase 3 trial of its experimental breast cancer drug gedatolisib.

The data showed that two- and three-drug combinations that included gedatolisib delayed disease progression more than a regimen with Novartis' Piqray plus hormone therapy, in patients whose tumors have PIK3CA mutations. The improvement was described as statistically significant and clinically meaningful.

The results will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting starting May 29. Celcuity has already filed for U.S. approval of gedatolisib, with a decision expected by July 17, and plans to submit the new data in a supplemental application to broaden the indication.