RARE Daily

Ideaya Receives Fast Track Designation for Darovasertib with Crizotinib to Treat Rare Eye Melanoma

December 5, 2022

The U.S. Food and Drug Administration has granted Fast Track designation to Ideaya Bioscience’s development program investigating darovasertib, a potential first-in-class protein kinase C inhibitor, for use in combination with crizotinib, an investigational cMET inhibitor, for the treatment of adult patients with the rare cancer metastatic uveal melanoma (MUM).

Photo: Darrin Beaupre, senior vice president and chief medical officer at Ideaya Biosciences

“The Fast Track designation acknowledges MUM as a serious condition and the potential for the darovasertib / crizotinib combination to treat this unmet medical need,” said Darrin Beaupre, senior vice president and chief medical officer at Ideaya Biosciences.

Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Under the Fast Track designation, the darovasertib / crizotinib development program in MUM is eligible for various expedited regulatory review processes, including generally more frequent FDA interactions such as meetings and written communications, potential eligibility for rolling review of a New Drug Application, and potential accelerated approval and priority review of an NDA.

Darovasertib was previously also designated as an Orphan Drug by the FDA in uveal melanoma (UM), including in MUM, entitling IDEAYA to certain potential tax credits, exemptions from user fees, and statutory marketing exclusivity.

Ideaya is targeting initiation of a potential registration-enabling trial for the darovasertib and crizotinib combination in MUM in the first quarter of 2023, subject to FDA feedback and guidance.

Ideaya is also planning to initiate a company-sponsored phase 1 clinical trial by the end of 2022 to evaluate darovasertib monotherapy in neoadjuvant UM patients. The preliminary development approach contemplates clinical endpoints such as organ preservation and/or vision preservation proximal to primary interventional treatments.

Author: Rare Daily Staff

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