Celcuity Makes Monumental Progress in Advancing Clinical Development of Gedatolisib for HR-Positive, HER2-Negative Advanced Breast Cancer
Celcuity continues to make significant strides in advancing clinical development of its flagship therapy, gedatolisib, for patients with HR-positive, HER2-negative advanced breast cancer. The company's latest quarterly update highlights a series of impressive milestones achieved in the second quarter of 2026.
According to Brian Sullivan, CEO of Celcuity, the FDA has approved REVTORPYK, a treatment regimen that combines gedatolisib with fulvestrant and/or palbociclib, for patients who have previously received endocrine therapy. This approval marks a major breakthrough in addressing the significant unmet need for tens of thousands of patients affected each year by HR-positive, HER2-negative advanced breast cancer.
Furthermore, Celcuity's VIKTORIA-1 study has produced positive results from the PIK3CA mutant cohort, with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) demonstrated for the gedatolisib triplet regimen compared to alpelisib plus fulvestrant. The median PFS was 11.1 months for the gedatolisib triplet versus 5.6 months for the alpelisib combination, with a hazard ratio of 0.5.
These results have been recognized by the National Comprehensive Cancer Network (NCCN), which has updated its guidelines to recommend both the REVTORPYK triplet and doublet regimens as preferred Category 1 treatments for second-line or subsequent treatment in tumors without a PIK3CA mutation. This endorsement highlights Celcuity's commitment to providing effective therapies for patients with advanced breast cancer.
Additionally, the company is on track to begin shipping REVTORPYK late in the third quarter of 2026 and plans to submit a supplemental NDA in the same period, based on the positive data from the PIK3CA mutant cohort. The VIKTORIA-2 study has also been expanded to include treatment-naive patients with endocrine-sensitive breast cancer, positioning gedatolisib regimens for potential use in nearly all first-line settings, regardless of endocrine sensitivity or PIK3CA status.
Celcuity's progress in advancing clinical development and commercialization of gedatolisib is a testament to the company's dedication to improving patient outcomes. As Sullivan noted, "we remain on track to address a significant unmet need for tens of thousands of patients affected each year by HR-positive, HER2-negative advanced breast cancer."
Celcuity's commitment to making REVTORPYK available to patients with advanced breast cancer is an exciting development that holds promise for those who have previously received endocrine therapy. The company's continued progress in advancing clinical development and commercialization of gedatolisib is a testament to its dedication to improving patient outcomes and addressing significant unmet needs in the field of oncology."
