Shots:
- FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26
- Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs 2mos.), ORR (32% vs 1%), & mDoR (17.5mos.) vs fulvestrant, while Revtorpyk + fulvestrant achieved an mPFS of 7.4 vs. 2mos., ORR of 28%, & mDoR of 12mos.
- Celcuity plans to submit an sNDA to the FDA in Q3’26 for Revtorpyk in HR+/HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer, following ≥1L of ET based on mutant cohort of VIKTORIA-1, followed by global regulatory submissions
Ref: Globenewswire | Image: Celcuity | Press Release
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