(ChemotherapyAdvisor) – The US FDA has designated the investigational targeted topoisomerase I inhibitor etirinotecan pegol (NKTR-102) as a fast track development program for treatment of women with locally recurrent or metastatic breast cancer that has progressed despite treatment with an anthracycline, a taxane and capecitabine (ATC). Biotechnology company Nektar Therapeutics announced the FDA’s decision November 7.
Etirinotecan pegol is undergoing phase 3 clinical testing in the BEACON (BrEAst Cancer Outcomes with NKTR-102) trial, with overall survival (OS) as a primary endpoint. Enrollment of 840 women with metastatic breast cancer into the BEACON study is scheduled to be complete by the end of 2013; enrollment in the study began in December 2011.
“Patients with advanced breast cancer who have progressed following ATC therapies have limited treatment options to manage their disease,” said Robert Medve, MD, chief medical officer at Nektar. “As a novel targeted topoisomerase I inhibitor, etirinotecan pegol is a different mechanism of action than currently approved therapies and has the potential to deliver improved efficacy while offering a more tolerable therapy for women with this aggressive disease.”
Because its molecular mechanism of action does not overlap with those of other breast cancer drugs, Medve believes the drug might reduce the risk of tumor cross-resistance and overlapping toxicities.
Under the FDA Modernization Act of 1997, the agency can designate fast track drug testing programs before or during new drug application (NDA) submission, when drugs demonstrate the potential to address unmet needs for life-threatening conditions. Nektar requested FDA fast track designation based on safety and efficacy data from preclinical, phase 1 and phase 2 clinical studies.