# FDA Approves Gedatolisib for HR+/HER2- PIK3CA Wild-Type Advanced Breast Cancer

> fda · REPORTED · 2026-07-14

The FDA approved gedatolisib (with fulvestrant, with or without palbociclib) on July 14, 2026 for hormone receptor-positive, HER2-negative advanced breast cancer, making it the first therapy specifically indicated for PIK3CA wild-type patients. The approval was based on the pivotal Phase 3 VIKTORIA-1 trial and received Priority Review and Breakthrough Therapy designation.

About Celcuity: Celcuity is a clinical-stage biopharmaceutical company developing targeted therapies for patients with HR-positive advanced breast cancer, focusing on PI3K/AKT/mTOR pathway inhibition.

- Company: Celcuity
- Sector: oncology
- Primary source: https://www.oncnursingnews.com/view/fda-approves-gedatolisib-for-hr-her2-advanced-breast-cancer-what-nurses-need-to-know

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.