Celcuity says NCCN guidelines add newly FDA-approved REVTORPYK for advanced HR+/HER2- breast cancer

Reuters2026/07/30 12:33

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Celcuity’s newly FDA-cleared REVTORPYK (gedatolisib) entered NCCN breast cancer treatment guidelines as a preferred second-line or later option.
The FDA clearance was granted on July 14, 2026 for HR+/HER2- locally advanced or metastatic breast cancer without a detected PIK3CA mutation.
The decision was supported by results already generated in the Phase 3 VIKTORIA-1 trial, which showed patients stayed on disease control longer versus fulvestrant alone.
The trial also showed more tumors shrank on REVTORPYK-based regimens than on fulvestrant alone.
Commercial availability in the US is expected in late Q3 2026, with an expanded access program planned ahead of launch.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607300830PRIMZONEFULLFEED9800824) on July 30, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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华尔街见闻•2026/08/16 07:46