IDEAYA Biosciences (IDYA) said Monday the US Food and Drug Administration granted breakthrough therapy designation to its experimental neoadjuvant treatment, darovarsetib, to treat adult patients with primary uveal melanoma.
The company said the decision was supported by interim data from an ongoing phase 2 trial, which showed 82% ocular tumor shrinkage and 61% eye preservation rates in patients.
IDEAYA said it plans to initiate a phase 3 trial for the therapy in H1 2025.
The breakthrough therapy designation accelerates developing and reviewing promising therapies for serious conditions, offering benefits such as intensive FDA guidance and priority review.
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