The US Food and Drug Administration (FDA) has granted fast track designation for IDEAYA Biosciences’ development programme studying darovasertib in combination with crizotinib to treat metastatic uveal melanoma (MUM).
Darovasertib is a potential first-in-class protein kinase C (PKC) inhibitor, and crizotinib is an investigational cMET inhibitor.
The designation will allow the darovasertib / crizotinib development programme to be eligible for various accelerated regulatory review processes that include potential eligibility for rolling review of a New Drug Application (NDA), accelerated approval, and priority review of an NDA.
IDEAYA Biosciences senior vice-president and chief medical officer Dr Darrin Beaupre said: “We are extremely pleased to receive the US FDA Fast Track designation as we prepare to initiate a potential Phase II/III registrational trial to evaluate the darovasertib and crizotinib combination in patients with MUM.
“The Fast Track designation acknowledges MUM as a serious condition and the potential for the darovasertib / crizotinib combination to treat this unmet medical need.”
Previously, the US FDA granted Orphan Drug designation to darovasertib in Uveal Melanoma (UM), including in MUM.
This designation entitled IDEAYA Biosciences to certain potential tax credits, exemptions from user fees, and statutory marketing exclusivity.
The company is currently preparing to initiate a potential registration-enabling trial to evaluate the darovasertib and crizotinib combination in MUM patients in the first quarter of next year. This is subject to FDA feedback and guidance.
It is also planning to commence a company-sponsored Phase I clinical trial to assess darovasertib monotherapy in neoadjuvant UM patients, in the fourth quarter this year.