FDA Accepts Revtorpyk Expansion Application for PIK3CA-Mutant Breast Cancer, Decision Due June 25, 2027
Celcuity Inc. (Nasdaq: CELC), a biotechnology company headquartered in Minneapolis, Minnesota, announced on November 9 that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for Revtorpyk (gedatolisib). The application seeks to expand the drug's use to patients with hormone receptor positive (HR+), HER2-negative locally advanced or metastatic breast cancer with a PIK3CA mutation, and the FDA assigned a Prescription Drug User Fee Act goal date of June 25, 2027.
The filing covers patients whose disease progressed on or after at least one line of endocrine therapy in the metastatic setting. It is based on clinical data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, and the drug previously received Breakthrough Therapy and Fast Track designations from the FDA.
"The FDA's acceptance of this sNDA takes us one step closer to bringing Revtorpyk to more patients living with HR+/HER2- locally advanced or metastatic breast cancer," said Brian Sullivan, Celcuity's chief executive officer and co-founder. If approved, he said, Revtorpyk would become available as second-line therapy regardless of a tumor's PIK3CA status.
Revtorpyk was first approved by the FDA on July 14, 2026, in combination with fulvestrant, with or without palbociclib, for patients in the same subtype without a detected PIK3CA mutation. HR+/HER2- is the most common breast cancer subtype, accounting for about 70 percent of all breast cancers, and about 40 percent of those tumors carry PIK3CA mutations, the company said.
Revtorpyk is a kinase inhibitor targeting class I PI3K isoforms and the mTOR complexes mTORC1 and mTORC2. The company's announcement also lists important safety information, including stomatitis, which occurred in up to 72 percent of patients in one combination group. Acceptance for review is not an approval; the FDA's decision is due by the June 25, 2027 goal date.
(Source: Celcuity)
Source: Celcuity Inc
Published by GSM · USA (original Chinese edition)
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