The U.S. Food and Drug Administration on Tuesday granted approval to Celcuity's gedatolisib, which will be sold under the brand name Revtorpyk. This marks the company’s first approved commercial product.
The approval was supported by late-stage clinical trial results showing that when gedatolisib is administered alongside Pfizer's Ibrance and the hormone therapy fulvestrant, the combination cut the risk of disease progression or death by 76% compared with fulvestrant alone.
Revtorpyk is indicated for a specific population of patients with advanced breast cancer. The authorized use is limited to tumors characterized by low expression of the HER2 protein and the absence of a mutation in the PIK3CA gene. Additionally, the approval applies to patients whose disease progressed following prior hormone therapy and a cyclin-dependent kinase (CDK) inhibitor.
In the pivotal trial, patients receiving the triple combination - gedatolisib with Ibrance and fulvestrant - experienced a median progression-free survival of 9.3 months. By contrast, patients treated with fulvestrant alone had a median progression-free interval of 2.0 months.
The market reacted to the FDA decision: shares of Celcuity rose 7% in afternoon trading on the announcement.
Context and data points
- The approval followed evaluation of late-stage clinical trial evidence.
- The regulatory action authorizes use in patients with HER2-low tumors that are PIK3CA wild-type, after progression on hormone therapy and a CDK inhibitor.
- Median progression-free survival was 9.3 months with the combination versus 2.0 months with fulvestrant alone; the combination reduced the risk of progression or death by 76% versus fulvestrant alone.
- Celcuity's stock climbed 7% in afternoon trading after the approval was announced.
Impacted sectors
- Biotechnology and pharmaceutical sectors, given the approval of a novel cancer therapy.
- Healthcare and medical markets, due to the targeted indication for a subgroup of breast cancer patients.
- Public markets where Celcuity is traded, as evidenced by the immediate stock-price reaction.
Notes
The information above reflects the FDA approval details and trial outcomes cited in the regulatory announcement and the market response reported on the day of approval.