Neoadjuvant Darovasertib Receives FDA Breakthrough Therapy Designation for Uveal Melanoma
Source: OncLive, April 2025
Updated interim phase 2 data showed the clinical efficacy and safety of neoadjuvant darovasertib monotherapy in localized uveal melanoma.
The FDA has granted breakthrough therapy designation to neoadjuvant darovasertib (IDE196) monotherapy for the treatment of adult patients with uveal melanoma.
The breakthrough therapy designation application was supported by updated interim findings from an ongoing, open-label, company-sponsored phase 2 IDE196-009 trial (NCT05907954) investigating the agent as monotherapy in the neoadjuvant setting in patients with localized uveal melanoma. Investigators plan to present updated data from this trial at medical meetings in mid-2025 and the second half of 2025, Yujiro S. Hata, president and chief executive officer of IDEAYA Biosciences—the developer of darovasertib—stated in a news release. Updated data that were submitted as part of the breakthrough therapy designation and are pending presentation include efficacy, safety, eye preservation, vision preservation/improvement during treatment, and radiation reduction.