Dr Brufsky on the FDA Approval of Gedatolisib Plus Fulvestrant ± Palbociclib in PIK3CA Wild-Type Breast Cancer

“Most of us are excited about this drug because it offers an option in the area where we don’t have much.”

Adam M. Brufsky, MD, PhD, a professor of medicine and the associate division chief for the Division of Hematology/Oncology in the Department of Medicine at the University of Pittsburgh School of Medicine; as well as medical director of the Magee-Women’s Cancer Program, associate director for clinical investigations, and codirector of the Comprehensive Breast Cancer Center at the University of Pittsburgh Medical Center Hillman Cancer Center, discussed the significance of the FDA approval of gedatolisib (Revtorpyk) plus fulvestrant (Faslodex), with or without palbociclib (Ibrance), for the treatment of adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation following progression on or after treatment with 1 or more lines of endocrine therapy in the metastatic setting.

This July 14, 2026, regulatory decision was backed by the results of the PIK3CA wild-type cohort (Study 1) of the phase 3 VIKTORIA-1 trial (NCT05501886).

Brufsky explained that the trial compared fulvestrant alone against gedatolisib plus fulvestrant and gedatolisib plus palbociclib and fulvestrant in the PIK3CA wild-type population. The median progression-free survival (PFS) was 9.3 months (95% CI, 7.2-16.6) with the triplet and 7.4 months (95% CI, 5.5-9.9) with the doublet, compared with 2.0 months (95% CI, 1.8-2.3) with fulvestrant alone, he reported.

He reported an HR of 0.24 (95% CI, 0.17-0.35; P < .0001) favoring the triplet over fulvestrant alone and 0.33 (95% CI, 0.24-0.48; P < .0001) favoring the doublet over fulvestrant alone. Regarding safety, Brufsky identified mucositis as the only significant toxicity, with grade 3 severe mucositis occurring in several patients despite prophylactic steroid mouthwash. Notably, rates of treatment discontinuations due to treatment-related adverse effects were low, attributable to prompt gedatolisib dose reductions, he explained. Brufsky characterized gedatolisib as well tolerated, lacking the associations with severe rash or hyperglycemia seen with alpelisib (Piqray), capivasertib (Truqap), or inavolisib (Itovebi).

Brufsky concluded that this approval represents a major advance in a setting with few treatment options, with its primary limitation being the regimen’s intravenous administration.