FDA Approves Revtorpyk to Cut Advanced Breast Cancer Progression Risk by 76%
The U.S. Food and Drug Administration (FDA) approved gedatolisib, marketed as Revtorpyk, a new intravenous drug developed by Selecta Biosciences for advanced breast cancer treatment. This marks the company's first product to reach the market. The approval is based on clinical data showing that combining Revtorpyk with Pfizer's Palbociclib (Ibrance) and AstraZeneca's Fulvestrant (Faslodex) 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 2 months for those on Fulvestrant only. The drug is administered weekly via intravenous infusion.
Revtorpyk targets patients with hormone receptor-positive, HER2-low advanced breast cancer without PIK3CA gene mutations, particularly those who have progressed after hormonal therapy and CDK inhibitors. This breast cancer subtype is the most common and often develops resistance to initial treatments. Unlike other drugs targeting a single component, Revtorpyk inhibits multiple elements of the PI3K pathway, a key driver of tumor growth and treatment resistance. Selecta aims to position Revtorpyk as a treatment option for patients lacking PIK3CA mutations, a group with fewer targeted therapies available.
The FDA approval relied on the VIKTORIA-1 trial, a randomized, multicenter, open-label study involving 392 women with advanced hormone receptor-positive, HER2-negative breast cancer. Participants were randomized into three groups: triple therapy (Revtorpyk, Ibrance, Faslodex), double therapy (Revtorpyk and Faslodex), and control (Faslodex alone). Both combination groups showed statistically significant improvements in progression-free survival, with median durations of 9.3 and 7.4 months respectively, compared to 2 months in the control group. Overall response rates were 32% for the triple combination, 28% for the double, and 1% for control. Survival data remain preliminary, with 25% mortality at the time of analysis.
Revtorpyk’s safety profile includes warnings for oral mucositis, skin reactions, elevated blood sugar, and fetal toxicity. Treatment cycles last 28 days with weekly 30-minute infusions. Selecta plans to begin marketing Revtorpyk in the third quarter of 2024. CEO Brian Sullivan highlighted a long-term opportunity to treat over 130,000 breast cancer patients, including potential first-line use, in a market valued at over $10 billion. Revtorpyk enters a competitive landscape alongside AstraZeneca’s Capivasertib, Novartis’s Alpelisib, and Eli Lilly’s Abemaciclib.
