Mesothelioma Treatment Granted Orphan Drug Designation

Verastem announced that the FDA has granted Orphan Drug designation to VS-5584 for the treatment of mesothelioma. VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2.

RELATED: Malignant Pleural Mesothelioma Therapy Designated Orphan Drug Status

Currently a Phase 1 dose escalation trial for VS-5584 is ongoing in patients with advanced solid tumors as a single agent. Some patients have been in the advanced solid tumor study for over 6 months and the maximum tolerated dose of VS-5584 has not been reached. Verastem has also initiated a combination trial of VS-5584 and VS-6063 in patients with relapsed or progressive malignant pleural mesothelioma.

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