Debiopharm announced that the FDA has granted Fast Track designation to the combination of its PKMYT1 inhibitor, lunresertib (Debio 2513), and its WEE1 inhibitor, zedoresertib (Debio 0123), for the treatment of adult patients with platinum‑resistant or refractory ovarian cancer characterized by CCNE1 amplification or a deleterious mutation in either FBXW7 or PPP2R1A.
The FDA’s Fast Track program is intended to facilitate the development and expedite the review of new drugs that are designed to treat serious conditions and address unmet medical needs. Programs with Fast Track designation may benefit from more frequent FDA interactions and, if certain criteria are met, eligibility for Priority Review and Accelerated Approval of a New Drug Application.
The designation follows initial clinical data from the MYTHIC study (NCT04855656), a Phase I trial evaluating lunresertib in combination with zedoresertib in patients with advanced solid tumors harboring the specified genomic alterations. These data were presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting 2026.
Debiopharm stated that the lunresertib–zedoresertib combination targets the DNA damage response (DDR) pathway through dual inhibition of PKMYT1 and WEE1, aiming to exploit genomic vulnerabilities related to CCNE1, FBXW7, or PPP2R1A and induce tumor cell death. Lunresertib is described as a first‑in‑class, oral PKMYT1 inhibitor designed to induce synthetic lethality in solid tumors with specific genetic alterations and is currently the most advanced PKMYT1 inhibitor in clinical development within the MYTHIC trial.
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