FDA Grants Fast Track Designation to Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer

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Nektar Therapeutics announced that the FDA has designated etirinotecan pegol (NKTR-102) as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC).  Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed using Nektar’s proprietary polymer conjugate technology. The drug candidate is currently being evaluated in a phase III study in women with metastatic breast cancer.

“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 of Nektar Therapeutics. “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.”

Nektar requested Fast Track designation from the FDA for etirinotecan pegol based upon its safety and efficacy profile to date from the nonclinical and clinical phase I and phase II studies, as well as its potential to deliver better efficacy and a more tolerable therapy for patients with locally recurrent or metastatic breast cancer progressing after treatment with ATC.  The agent was designed to improve the efficacy of irinotecan by modifying the distribution of the drug candidate within the body. Etirinotecan pegol has a nonoverlapping mechanism of action with other agents used to treat breast cancer which may mitigate potential cancer cross-resistance and reduce overlapping toxicities.

Phase III Study Now Enrolling

The phase III BEACON study will enroll approximately 840 patients with metastatic breast cancer who have had prior treatment with ATC in either the adjuvant or metastatic setting. The primary endpoint of the BEACON study is overall survival. Secondary endpoints include progression-free survival, objective tumor response rates, clinical benefit rate, duration of response, pharmacokinetic data, safety, quality-of-life measurements, and measurement of healthcare resource utilization for the two study arms. Exploratory objectives of the study include collecting specific biomarker data which will be correlated with efficacy outcome measures. Enrollment in the BEACON study began in December 2011 and is expected to be completed by the end of 2013. ■ 




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