Gedatolisib Approval in HR+/HER2- Breast Cancer May Be “Practice Changing”

Following the FDA approval of the pan-PI3K and mTOR inhibitor gedatolisib (Revtorpyk) in combination with fulvestrant, with or without palbociclib (Ibrance), for hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, clinicians are evaluating how this treatment will integrate into oncology practices.¹

The approval was driven by efficacy data from the phase 3 VIKTORIA-1 trial (NCT05501886).² Sara Hurvitz, MD, FACP, shared her clinical perspective on why this newly approved regimen represents an immediate paradigm shift. Hurvitz discussed the robust progression-free survival benefit observed across patient populations. Additionally, she addressed the logistics of transitioning to an intravenous (IV) administration schedule for a PI3K pathway inhibitor, noting that oncology clinics are already well equipped to handle the scheduling without disrupting standard workflow patterns.

Hurvitz is a physician, senior vice president and director of the Clinical Research Division, professor of the Clinical Research Division, and Smith Family Endowed Chair in Women’s Health at Fred Hutch.

Transcript:

In my opinion, this [approval] could be immediately practice changing. The progression-free survival data that we’re seeing in both the PIK3CA wild-type and PIK3CA-mutant populations were consistently better than the control arm and are meaningful for patients. Oncologists and patients are familiar with IV administration of many of our most effective therapeutics. It’s not as though we have to learn how to do that. There is more of a commitment in terms of going to the clinic, but when I’m starting patients on a PI3K pathway inhibitor, we’re already seeing them on an intensive schedule, especially in the first few months when we’re starting them on therapy because the typical PI3K pathway inhibitors that we use are associated with a lot of toxicity that requires intensive monitoring. This one does not have as much of that toxicity, but patients will still need to come in and receive therapy. I don’t think [the gedatolisib approval is] going to represent a major change in the way we implement care.

References

1. FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer. News release. FDA. July 14, 2026. Accessed Jully 15, 2026. https://tinyurl.com/yck3eabf
2. Hurvitz SA, Layman RM, Curigliano G, et al. Gedatolisib Plus fulvestrant, with & without palbociclib, vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: first results from VIKTORIA-1. Presented at: 2025 ESMO Annual Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA17.