The FDA has approved Celcuity’s kinase inhibitor gedatolisib, branded as Revtorpyk, for use in combination with other therapies to treat certain patients with locally advanced or metastatic breast cancer, according to a July 15 announcement. Revtorpyk is the company’s first commercial product and will be launched in the U.S. in late third quarter of this year. Celcuity said it plans to implement a comprehensive patient support program but has not yet disclosed pricing for the drug.
Revtorpyk is indicated for use alongside AstraZeneca’s Faslodex, with or without Pfizer’s Ibrance, in patients who have HR-positive, HER2-negative metastatic or locally advanced disease without detectable PI3KCA mutations after progression on at least one prior line of endocrine therapy. The approval positions Celcuity uniquely among competitors whose PI3K/AKT inhibitors target patients positive for PI3KCA mutations.
According to analysts at Jefferies, this gives Celcuity a “differentiated foothold” in the breast cancer space and shifts investor attention toward how effectively the company can execute its launch and integrate Revtorpyk into clinical practice. Jefferies also noted that investors are watching whether Revtorpyk could become a new targeted option for the sizeable second-line population.
Approval was based on data from the Phase 3 VIKTORIA-1 trial. Median progression-free survival (PFS) reached just over nine months with the three-drug regimen including Revtorpyk compared to two months with Faslodex alone. When used without Ibrance, Revtorpyk plus Faslodex resulted in a median PFS of 7.4 months.
Additional data released earlier this summer showed that adding Revtorpyk produced a 50% PFS benefit versus Faslodex plus Piqray—a current standard-of-care regimen—in patients harboring PI3KCA mutations; improvement was 49% when combined only with Faslodex. In their June 2 note to investors, Jefferies analysts wrote, “These findings are ‘practice-changing in our view.’ The Revtorpyk triplet ‘doubled PFS’ versus Piqray comparators, ‘a meaningful improvement vs SOC that could drive near-term rapid uptake.’”
Celcuity said it plans to file a supplemental package based on these results from PI3KCA-mutant cohorts later this quarter and continues testing Revtorpyk as a first-line option in an ongoing Phase 3 trial.
