Roughly 37,000 women with advanced breast cancer in the United States currently have no good treatment options after their disease progresses on standard first-line therapy. In four days, the FDA could change that.
The agency faces a July 17, 2026 deadline to decide whether to approve gedatolisib, an investigational drug developed by Celcuity, for patients with hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The drug received both Priority Review and Breakthrough Therapy designation from the FDA — two designations the agency reserves for therapies addressing serious unmet medical needs.
