Celcuity files FDA application for Revtorpyk in breast cancer

By Ahmed Jamerson • Wednesday, August 26 16:04 • Permanent Link

Celcuity said Tuesday it has filed a supplemental new drug application with the FDA seeking to expand Revtorpyk to patients with HR+/HER2* locally advanced or metastatic breast cancer carrying a PIK3CA mutation after at least one prior line of endocrine therapy.

The filing is backed by phase 3 VIKTORIA-1 data in the PIK3CA-mutant cohort, where the Revtorpyk triplet — gedatolisib plus fulvestrant and palbociclib — cut the risk of disease progression or death by 50% versus alpelisib plus fulvestrant, with a hazard ratio of 0.50. Median progression-free survival was 11.1 months, compared with 5.6 months for the comparator.

The Revtorpyk doublet — gedatolisib plus fulvestrant — showed a 49% reduction in the risk of progression or death versus alpelisib plus fulvestrant, with a hazard ratio of 0.51. Median progression-free survival was 11.3 months, also versus 5.6 months.

Response data also favored the Revtorpyk regimens. The triplet posted a 49% objective response rate and a median duration of response of 15.7 months. The doublet delivered a 36% objective response rate and a median duration of response of 24.2 months.

Celcuity said the PIK3CA-mutant cohort included 350 patients, randomly assigned in a 3:3:1 ratio to the triplet, alpelisib plus fulvestrant, or the doublet.

The company’s first FDA approval for Revtorpyk came on July 14, 2026, for HR+/HER2 advanced breast cancer without a detected PIK3CA mutation. Celcuity is now seeking to extend the drug into the mutation-positive population, which it said represents about 40% of HR+/HER2 breast cancers.

In the broader VIKTORIA-1 study, 701 patients were enrolled overall, regardless of PIK3CA status. The market has reacted to these announcements by moving the company's shares 3.1% to a price of $95.13. For the full picture, make sure to review Celcuity's 8-K report.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.