NDA Submission of Gedatolisib in PIK3CA WT Cohort in HR+/HER2- Advanced Breast Cancer to be Initiated Under FDA’s RTOR Program
“On the heels of announcing positive pivotal data last month, we are pleased that the FDA agreed to review our NDA application for gedatolisib under the RTOR program,” said Brian Sullivan, CEO and co-founder of Celcuity. “Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on our promising preliminary clinical data. The FDA’s decision further highlights the urgent need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. We look forward to working with the FDA to complete the review of our NDA for gedatolisib.”
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