The U.S. Food and Drug Administration has approved gedatolisib, marketed as Revtorpyk, for certain women with advanced breast cancer after a clinical trial found that a three-drug combination reduced the risk of disease progression or death by 76%.
The drug, developed by biotechnology company Celcuity, is the first company product to reach the market.
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The drug is administered by intravenous infusion once a week. Illustration
(Photo: Shutterstock)
Revtorpyk was approved in combination with Pfizer’s palbociclib, sold as Ibrance, and AstraZeneca’s fulvestrant, sold as Faslodex.
Patients receiving the three-drug regimen remained alive without their disease worsening for a median of 9.3 months, compared with two months among those treated with Faslodex alone.
The treatment is intended for patients with hormone receptor-positive, HER2-negative advanced breast cancer whose disease progressed after hormone therapy and treatment with a CDK inhibitor, a class of drugs that slows the division of cancer cells.
It is specifically approved for patients whose tumors do not carry a PIK3CA mutation, a group with fewer targeted treatment options.
Hormone receptor-positive, HER2-negative cancer is the most common form of breast cancer. Many patients initially receive hormone therapy combined with a CDK inhibitor, but the cancer may eventually become resistant, requiring additional treatment options.
Revtorpyk targets the PI3K signaling pathway, which plays a major role in tumor growth and treatment resistance. Unlike several existing drugs that generally target a single component of the pathway, gedatolisib acts on multiple components simultaneously.
Celcuity plans to begin marketing the drug during the third quarter of the year.
The approval was based on the VIKTORIA-1 trial, an open-label, randomized study involving 392 adults with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer.
Participants were assigned to one of three groups: Revtorpyk combined with Ibrance and Faslodex; Revtorpyk combined with Faslodex; or Faslodex alone.
The three-drug regimen produced a statistically significant improvement in progression-free survival, reaching a median of 9.3 months. Patients receiving Revtorpyk and Faslodex without Ibrance had a median progression-free survival of 7.4 months.
The overall response rate was 32% in the three-drug group and 28% in the two-drug group, compared with 1% among patients receiving Faslodex alone.
Overall survival data remain incomplete. At the time progression-free survival was analyzed, deaths had occurred among approximately 25% of the trial participants.
The medication is administered through a 30-minute intravenous infusion once a week in 28-day treatment cycles.
Its prescribing information includes warnings concerning inflammation and sores in the mouth, skin reactions, elevated blood sugar and potential harm to a developing fetus.
Celcuity CEO Brian Sullivan said the company sees a long-term opportunity to treat more than 130,000 breast cancer patients, including through possible use as a first-line therapy. The company estimates that market could be worth more than $10 billion.