FDA Approves New Drug Revtorpyk to Significantly Delay Advanced Breast Cancer Progression

The U.S. Food and Drug Administration (FDA) has approved a new treatment called Revtorpyk (gedatolisib) for patients with advanced or metastatic hormone receptor-positive (HR+) and HER2-negative breast cancer whose disease progressed despite prior hormonal therapy. This subtype represents the most common form of breast cancer, where many patients initially respond to hormonal treatments but often develop resistance over time, limiting further options.

Revtorpyk is not administered alone; it is combined with the hormonal therapy Fulvestrant (Faslodex) and, in some cases, with Palbociclib (Ibrance). The drug works by inhibiting tumor cell mechanisms that enable cancer growth and spread after previous treatments have failed. The FDA's approval is based on the phase 3 VIKTORIA-1 trial involving 392 patients, which showed that the combination of Revtorpyk with Fulvestrant and Palbociclib reduced the risk of disease progression or death by 76% compared to Fulvestrant alone. Patients receiving the triple combination experienced a median progression-free survival of 9.3 months, versus only 2 months in the control group. The combination of Revtorpyk with Fulvestrant alone also showed improved outcomes, with a median progression-free survival of 7.4 months.

However, the FDA notes that it is still too early to confirm whether the treatment extends overall survival, as those data are immature. The therapy is specifically indicated for women without PIK3CA gene mutations whose cancer progressed after hormonal therapy and CDK4/6 inhibitor treatment. Eligibility is determined through molecular tumor testing and oncologist evaluation.

Common side effects include mouth inflammation and sores, skin reactions, and elevated blood sugar levels. Revtorpyk is administered intravenously once weekly in 28-day cycles. Currently, the drug is approved only in the United States; it must undergo regulatory review before potential availability in Israel, including possible evaluation by the national health basket committee.