Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer
Thursday, July 30, 2026 BiopharmaWatch Research 1 min read
Key Takeaway: REVTORPYK (gedatolisib) has been FDA-approved and is now included in the NCCN Clinical Practice Guidelines as a preferred treatment option for HR+/HER2- locally advanced or metastatic breast cancer. It is recommended for use in combination with fulvestrant, with or without palbociclib, for patients without a PIK3CA mutation after prior endocrine therapy. This approval marks a significant advancement in breast cancer treatment.
Price reaction · baseline $83.26 (2026-07-29 close) · hit pre-market · clean, no other CELC news in the window
day 0 close
+5.3%
day 1
+3.7%
day 3 · peak
+11.1%
Market Sentiment Analysis
POSITIVE FACTORS
REVTORPYK is FDA-approved, enhancing treatment options.
Inclusion in NCCN guidelines signifies strong clinical support.
Preferred Category 1 regimen indicates high efficacy.
BiopharmaWatch Analysis
From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+27%
120-day peak, hindsight
Typical move
14.9%
average across 6 past catalysts
Cash runway
~41 mo
Minimal dilution risk
Lead asset
Gedatolisib
Phase 3 · Breast Cancer
Full Press Release Details
REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, listed as a preferred Category 1 regimen for second-line or subsequent treatment for tumors without a PIK3CA mutation following progression on or after at least one line of endocrine therapy MINNEAPOLIS, July 30,
Frequently Asked Questions
What is REVTORPYK used for?
REVTORPYK is used for treating HR+/HER2- locally advanced or metastatic breast cancer.
What does NCCN recommend for REVTORPYK?
NCCN recommends REVTORPYK as a preferred Category 1 regimen for certain breast cancer patients.
What treatments can REVTORPYK be combined with?
REVTORPYK can be combined with fulvestrant, with or without palbociclib.
What is the significance of the FDA approval?
The FDA approval enhances treatment options for patients with specific breast cancer types.