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IDEAYA: Darovasertib+ Crizotinib Combination Therapy Gets FDA Fast Track Designation For MUM

IDEAYA Biosciences, Inc. (IDYA), a synthetic lethality focused precision medicine oncology company, announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation for Darovasertib combination therapy with Crizotinib to treat adult patients with metastatic uveal melanoma or MUM.

The designation will enable darovasertib / crizotinib development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review.

Darovasertib is a potential first-in-class protein kinase C or PKC inhibitor, and crizotinib is an investigational cMET inhibitor.

Fast Track is a U.S. FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Darovasertib was earlier designated as an Orphan Drug by the FDA in Uveal Melanoma or UM, including in MUM. This entitles IDEAYA to certain potential tax credits, exemptions from user fees, and statutory marketing exclusivity.

IDEAYA said it is preparing to initiate a potential Phase 2/3 registrational trial to evaluate the darovasertib and crizotinib combination in patients with MUM in the first quarter of fiscal 2023, subject to FDA feedback and guidance.

IDEAYA is also planning to initiate a company-sponsored Phase 1 clinical trial in the fourth quarter this year to evaluate darovasertib monotherapy in neoadjuvant UM patients.

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