FDA Approves New Treatment for Advanced Breast Cancer

The U.S. Food and Drug Administration has approved gedatolisib (Revtorpyk) for patients with advanced hormone receptor-positive, HER2-negative breast cancer that has progressed after prior endocrine therapy. This marks the first approval for a drug that simultaneously inhibits class I PI3K isoforms and both mTOR complexes. The decision is based on positive Phase 3 trial results showing improved progression-free survival, with a commercial launch anticipated in late Q3 2026.