Erica Stringer-Reasor, MD, on Gedatolisib's FDA Approval in Breast Cancer

The FDA's approval of gedatolisib¹ (Revtorpyk) marks a notable shift for patients with hormone receptor–positive, HER2-negative advanced breast cancer whose tumors don't carry a PIK3CA mutation—a group that makes up approximately 35% to 40% of this population and, until now, has had few targeted options once first-line CDK4/6 inhibitor therapy stops working. Approved in combination with fulvestrant (Faslodex), with or without palbociclib (Ibrance), gedatolisib is the first therapy cleared to inhibit both the PI3K and mTOR pathways at once, an approach designed to address the resistance mechanisms that limit single-pathway drugs. In the pivotal phase 3 VIKTORIA-1 trial (NCT05501886), the combination substantially extended progression-free survival compared with fulvestrant alone.