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Breast Cancer Drug REVTORPYK Gains FDA Approval
14 Aug
Summary
- REVTORPYK therapy for advanced breast cancer approved by FDA.
- Commercial shipments to begin late Q3 2026.
- Gedatolisib triplet showed over 11 months progression-free survival.
Celcuity announced FDA approval for its REVTORPYK therapy, a treatment for specific advanced breast cancer patients. Commercial shipments are expected to begin by the end of the third quarter of 2026. The National Comprehensive Cancer Network has designated both the triplet and doublet gedatolisib regimens as preferred Category 1 treatment options.
Clinical trial data presented at the ASCO annual meeting highlighted the efficacy of gedatolisib. In patients without a PIK3CA mutation, the gedatolisib triplet demonstrated a median progression-free survival of 11.1 months. This is a notable improvement compared to the 5.6 months seen with the current standard of care.
The company plans to submit a supplemental new drug application in the third quarter. This submission will seek to include data from the PIK3CA-mutant cohort of its Phase III VIKTORIA-1 trial. Celcuity will also submit VIKTORIA-1 trial data from both wild-type and mutant cohorts to global regulatory bodies.
