The FDA granted orphan drug designation (ODD) to Nuvectis Pharma’s (NASDAQ:NVCT) oral GCN2 activator, NXP800, for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. The ODD could lead to seven years of marketing exclusivity in the US for NXP800 for these specific cancers.
Previously, the FDA awarded fast-track designation to NNP800 for platinum-resistant ovarian carcinoma and ODD for cholangiocarcinoma. NXP800 is currently part of an investigator-sponsored trial for cholangiocarcinoma treatment.
In a statement, Ron Benstur, chairman and CEO of Nuvectis, said, “We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000-patient threshold below which drugs may be eligible to receive orphan drug designation in the U.S., and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease.”
“We therefore believe that this orphan drug designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800’s mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum-resistant, ARID1a-mutated ovarian cancer,” he added.
