Therapy Areas
IDEAYA Biosciences receives FDA Fast Track designation for development program investigating darovasertib in combination with crizotinib
6 December 2022 -

IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a US-based synthetic lethality focused precision medicine oncology company involved in the discovery and development of targeted therapeutics, announced on Monday that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for its development program investigating darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for use in combination with crizotinib, an investigational cMET inhibitor, to treat adult patients with metastatic uveal melanoma (MUM).

The Fast Track designation allows the darovasertib/crizotinib development program in MUM to be eligible for various accelerated regulatory review processes, which include generally more frequent FDA interactions, potential eligibility for rolling review of a New Drug Application (NDA) and potential accelerated approval and priority review of an NDA.

The company is also planning to start a company-sponsored Phase one clinical trial in the fourth quarter of 2022 to assess darovasertib monotherapy in neoadjuvant UM patients.