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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

within the body. As a new topoisomerase I inhibitor, etirinotecan pegol has a non-overlapping mechanism of action with other agents used to treat breast cancer which may mitigate potential cancer cross-resistance and reduce overlapping toxicities.

Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment for serious or life-threatening conditions, which demonstrate the potential to address an unmet medical need for such conditions. The Fast Track program enables a company to file sections of an NDA on a rolling basis as data becomes available. This permits the FDA to review portions of the NDA as they are received, rather than waiting for the entire NDA filing prior to commencing the review process. With a Fast Track designation, there is the possibility of a priority review and a more opportunity for more frequent interactions with the FDA, which could decrease the typical development time and review period.

About the Phase 3 BEACON Study of Etirinotecan PegolThe BEACON Study (EAst Cancer Outcomes with NKTR-102) will enroll approximately 840 metastatic breast cancer patients who have had prior treatment with ATC in either the adjuvant or metastatic setting. The primary endpoint of the BEACON study is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective tumor response rates (ORR), clinical benefit rate, duration of response, pharmacokinetic (PK) 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.

About Metastatic Breast Can
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SOURCE Nektar Therapeutics
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