Supplemental NDA submitted to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
“The recent FDA approval of REVTORPYK marked an important milestone for Celcuity and for patients with PIK3CA wild-type HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “We are deeply committed to expanding the availability of REVTORPYK to a broader population of patients. We look forward to working collaboratively with the FDA on this application to potentially bring this treatment to patients with PIK3CA mutated locally advanced or metastatic breast cancer.”
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