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Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
Date:11/7/2012

SAN FRANCISCO, Nov. 7, 2012 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) announced today that the U.S. Food and Drug Administration (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 3 study in women with metastatic breast cancer.

"We are very pleased that the etirinotecan pegol development program in breast cancer has been granted Fast Track designation and we look forward to continuing to work closely with the FDA on this program," said Robert Medve, MD, Chief Medical Officer of Nektar Therapeutics. "Patients with advanced breast cancer who have progressed following ATC therapies have limited treatment options to manage their disease. 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 what is known about its safety and efficacy profile to-date from the nonclinical, Phase 1 and Phase 2 clinical studies, as well as etirinotecan pegol's potential to deliver better efficacy and a more tolerable therapy for patients with locally recurrent or metastatic breast cancer progressing after treatment with ATC.  Etirinotecan pegol, a new topoisomerase I inhibitor, was designed to improve the efficacy of irinotecan by modifying the distribution of the drug candidate
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SOURCE Nektar Therapeutics
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