Managing Gedatolisib IV Delivery and Toxicity Profiles in Breast Cancer

The FDA approval of gedatolisib (Revtorpyk) introduced an intravenous therapeutic option for patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer after progressing on endocrine therapy. ¹While oral agents targeting the PI3K/AKT/mTOR pathway have historically been standard, they frequently present clinicians with significant toxicity management challenges. The approval was based on results from the phase 3 VIKTORIA-1 trial (NCT05501886), where specific adverse effects (AEs) were noted.²

Sara Hurvitz, MD, FACP, analyzed the practical aspects of utilizing an intravenous (IV) formulation in the clinic. Hurvitz pointed out that oncology practices are already highly accustomed to handling complex IV therapeutics, such as antibody-drug conjugates. Furthermore, she highlighted how the routine clinic visits required for weekly intravenous infusions can optimize patient care by facilitating closer clinical oversight and enhancing overall treatment adherence. Importantly, she described how the superior safety profile of gedatolisib helps offload typical clinic burdens by reducing the incidence of severe AEs traditionally associated with this therapeutic pathway.

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

Transcript:

My answer is going to be twofold here. First, as I mentioned earlier, we as oncologists are facile with IV formulations of treatments. We’re using antibody drug conjugates, of course. The uptake has been tremendous, and those are IV formulations. The uptake is because of that superior efficacy that we’re seeing even against oral chemotherapy. I don’t think that’s going to be a major impediment to utilizing this therapy, and in many ways, it may enable oncologists to have more careful monitoring of patients while they’re on therapy and starting therapy, which may help with adherence. We know that the toxicity profile is better. When you’re not having to deal with significant toxicities such as rash, diarrhea, and hyperglycemia [at] the extent that you do with other drugs that target this pathway, that offloads the clinic requirements in many ways.

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.