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IDEAYA is targeting initiation of a potential registration-enabling trial for the darovasertib and crizotinib combination in MUM in Q1 2023, subject to FDA feedback and guidance

IDEAYA Biosciences Receives Fast Track Designation for Darovasertib Combination Therapy with Crizotinib for the Treatment of Metastatic Uveal Melanoma

IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA's development program investigating darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for use in combination with crizotinib, an investigational cMET inhibitor, for the treatment of adult patients with metastatic uveal melanoma

By AP News
Published - Dec 05, 2022, 06:14 AM ET
Last Updated - Apr 04, 2024, 10:52 AM EDT
  • Fast Track designation granted by U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM)
  • Enables darovasertib / crizotinib development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review
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