Repare Therapeutics Inc. announced the U.S. Food and Drug Administration 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. 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 June 4, 2024, 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 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.