On June 4, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer (Press release, Repare Therapeutics, JUN 4, 2024, View Source [SID1234644106]).
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Lunresertib in combination with camonsertib is currently being evaluated in Repare’s MYTHIC Module 2 Phase 1 dose expansion clinical trial at the recommended Phase 2 dose in patients with ovarian and endometrial cancers harboring CCNE1 amplification or FBXW7 or PPP2R1A mutations. In addition to the Fast Track designation announced today, the FDA previously granted Fast Track designation to lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A mutated endometrial cancer in the third quarter of 2023. Repare expects to present data from the MYTHIC Module 2 dose expansion cohorts in approximately 20-30 patients each with ovarian and endometrial cancer in the fourth quarter of 2024.
"The FDA’s decision to grant Fast Track designation supports our goal of quickly and efficiently developing the lunresertib-camonsertib combination for patients with genomically-defined platinum-resistant ovarian cancer," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "Ovarian cancer patients need therapies that provide long-term benefit beyond that observed with standard of care. Our precision medicine approach targets treatment to patients who could most benefit from a well-tolerated alternative to chemotherapy."
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients earlier. Companies whose programs are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review, if relevant criteria are met. For more information on Fast Track Designation, please visit the FDA’s website at View Source
About Repare Therapeutics’ SNIPRx Platform
Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.