IDEAYA Gets FDA Orphan Designation for Darovasertib in Uveal Melanoma
May 02 2022 - 6:49AM
Dow Jones News
By Colin Kellaher
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 02, 2022 06:34 ET (10:34 GMT)
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