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IDEAYA Biosciences Receives US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma
Designation enables expedited development and priority regulatory reviewBTD application was supported by updated clinical data from Ph2 neoadjuvant UM trial
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"Designation enables expedited development and priority regulatory reviewBTD application was supported by updated clinical data from Ph2 neoadjuvant UM trial that we are targeting to present at medical conferences in mid-2025 and H2 2025Targeting to initiate a Ph3 registrational study in neoadjuvant UM in H1 2025Neoadjuvant UM has a projected annual incidence of ~12k patients, and is a high unmet medical with no FDA approved systemic therapiesSOUTH SAN FRANCISCO, Calif., March 31, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended.\n\n \n \n \n \n \n \n\n \n\"We are pleased to receive FDA Breakthrough Therapy designation as we prepare to advance neoadjuvant darovasertib into a potential Phase 3 registrational trial in patients with primary UM. This designation highlights the potential of monotherapy darovasertib in a patient population with significant unmet medical need where there are currently no FDA-approved systemic therapies,\" said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. \"We are targeting to present the updated Phase 2 clinical data in neoadjuvant UM that was provided as part of the BTD application at multiple medical conferences in 2025,\" said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.\nThis U.S. FDA BTD designation, follows the Fast Track designation granted by the U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM), where a Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative MUM is ongoing. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in MUM, entitling IDEAYA to certain potential tax credits, exemptions from user fees, and statutory marketing exclusivity.\nThe BTD application was supported by updated interim clinical data from an ongoing P...