IDEAYA Gets FDA Orphan Designation for Darovasertib in Uveal Melanoma

 IDEAYA Biosciences Inc. on Monday said the U.S. Food and Drug Administration granted orphan-drug designation to darovasertib for the treatment of uveal melanoma, the most common primary intraocular cancer.

The South San Francisco, Calif., precision-medicine oncology company is currently evaluating darovasertib in combination with Pfizer Inc.'s cancer drug Xalkori in patients with metastatic uveal melanoma and in patients with GNAQ or GNA11 mutant solid tumors in a Phase 1/2 clinical trial as part of a collaboration with the New York drugmaker.

IDEAYA said it is targeting a mid-year clinical data update for the combination, including tolerability and clinical efficacy, adding that it also plans to seek FDA regulatory guidance for a potential registration-enabling trial design to evaluate the combination in metastatic uveal melanoma.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

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