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FDA Approves Revtorpyk for PIK3CA-Negative Breast Cancer

7/16/2026

Summary

FDA Approves

The U.S. FDA approved Celcuity’s Revtorpyk (gedatolisib) for second-line HR-positive, HER2-negative breast cancer.
The approval applies to tumors without PIK3CA mutations, representing about 60 % of 70 % of HR-positive, HER2-negative cases.
Phase 3 trials with Faslodex, and optionally Ibrance, demonstrated statistically significant progression-free survival while overall survival data remain immature.
Celcuity will file a supplemental NDA after the June 2026 ASCO presentation and estimates a U.S. market above $10 billion while planning worldwide submissions.

Summary

Celcuity Delays Supply

Revtorpyk triple regimen had a 12% discontinuation rate, largely due to mucositis, and common adverse events included stomatitis, skin reactions, and hyperglycemia.
Analyst Andrew Berens of Leerink Partners warned that community physicians must manage mucositis for commercial success.
Celcuity delayed the drug-supply rollout to the late quarter, contradicting earlier promises of post-FDA approval availability.
Investors expressed concern that the higher discontinuation rate and supply constraints could curb Revtorpyk’s market uptake.

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FDA Approves

The U.S. FDA approved Celcuity’s Revtorpyk (gedatolisib) for second-line HR-positive, HER2-negative breast cancer.
The approval applies to tumors without PIK3CA mutations, representing about 60 % of 70 % of HR-positive, HER2-negative cases.
Phase 3 trials with Faslodex, and optionally Ibrance, demonstrated statistically significant progression-free survival while overall survival data remain immature.
Celcuity will file a supplemental NDA after the June 2026 ASCO presentation and estimates a U.S. market above $10 billion while planning worldwide submissions.

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