FDA Approves Celcuity's Gedatolisib for Advanced Breast Cancer in First Commercial Win
The US Food and Drug Administration has approved gedatolisib, the first drug to reach market for Minneapolis-based Celcuity (CELC), granting the green light for a treatment targeting an advanced form of breast cancer in which existing options remain limited.
The drug, branded Revtorpyk, was approved in combination with Pfizer's (PFE) Ibrance and the hormone therapy fulvestrant. The approval was supported by late-stage trial data showing the three-drug regimen reduced the risk of disease progression or death by 76% compared with fulvestrant alone. Patients on the combination remained progression-free for a median of 9.3 months, against 2.0 months for those receiving fulvestrant alone.
Celcuity shares fell more than 5% in after-hours trading on Monday, having closed the regular session up 6.9%.
Revtorpyk is indicated for patients with hormone receptor-positive, HER2-negative advanced breast cancer — the most common form of the disease — whose tumors carry no mutation in the PIK3CA gene and who have progressed following hormone therapy and a CDK inhibitor. That patient group has historically had fewer targeted options than those with PIK3CA mutations.
The drug works by targeting the PI3K signaling pathway, a key driver of tumor growth and resistance to treatment. Unlike currently approved therapies that generally act on a single component of that pathway, gedatolisib inhibits multiple nodes simultaneously, a mechanism Celcuity believes may offer broader and more durable activity.
Brian Sullivan, Celcuity's chief executive, told investors the company sees a long-term opportunity to treat more than 130,000 breast cancer patients annually, including potential use in earlier lines of therapy, representing a total addressable market of more than $10 billion. The company expects to begin commercial launches in the third quarter.
Revtorpyk will enter a competitive field that includes AstraZeneca's (AZN) Truqap, Novartis' (NVS) Piqray and Eli Lilly's (LLY) Verzenio, all of which target overlapping patient populations in the hormone receptor-positive, HER2-negative advanced breast cancer setting.