INSILICO (03696) has announced that its AI-driven, potentially best-in-class pan-TEAD inhibitor, ISM6331, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA).

This designation is for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed following prior anti-PD-1 antibody therapy (with or without anti-CTLA-4 antibody treatment) and platinum-based chemotherapy.

Under FDA policy, the Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions and address unmet medical needs. With the Fast Track designation, ISM6331 will benefit from regulatory support aimed at accelerating clinical development, including more frequent meetings and written communications with the FDA to discuss clinical trial design, biomarker strategies, and the overall development plan.

Additionally, if relevant criteria are met, ISM6331 may be eligible for Accelerated Approval and Priority Review, and it can also utilize the Rolling Review process. Under the Rolling Review process, portions of a Biologics License Application (BLA) or New Drug Application (NDA) can be submitted to the FDA for review upon completion, without waiting for the entire application package to be ready.