Celcuity’s breast cancer drug, Revtorpyk, has been approved by the U.S. Food and Drug Administration (FDA) for certain patients with advanced breast cancer whose tumors do not carry a PIK3CA mutation.
Delayed Launch
The approval gives Celcuity its first marketed product, which is expected to launch late in the third quarter. The company cited the need to ensure adequate drug supply as the reason for the delay.
Revtorpyk, combined with Pfizer’s Ibrance and fulvestrant, reduced the risk of disease progression or death by 76% in a late-stage trial. Patients receiving the treatment went a median 9.3 months without their cancer worsening, compared with two months for those receiving fulvestrant alone.
The label warns that Revtorpyk can cause severe mouth inflammation and recommends preventive mouthwash. Mouth inflammation occurred in 72% of patients receiving the three-drug combination, including severe cases in 22%.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
