FDA Grants Orphan Drug Designation For IDEAYA's Darovasertib For Uveal Melanoma

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to IDEAYA Biosciences IDYA for its drug candidate Darovasertib for the treatment of uveal melanoma.

Darovasertib in combination with Crizotinib is being evaluated in an ongoing Phase 1/2 clinical trial in patients with metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11 mutant solid tumors.

Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, said, ”We are excited to advance darovasertib towards a potential registration-enabling trial in metastatic uveal melanoma, and the orphan-drug designation is an important step towards our goal to bring this novel therapy to patients”.

Orphan-drug designation (ODD) is granted by the U.S. Food and Drug Administration (FDA) to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the United States.

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