Nektar Therapeutics receives fast track designation for breast cancer drug

Comtex News Network

Nov 12, 2012 (Datamonitor via COMTEX) --Nektar Therapeutics, a biopharmaceutical company, has received fast track designation from the FDA for etirinotecan pegol for a development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine, or 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.

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 I and Phase II 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 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.

The BEACON Study (BrEAst 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.

"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, 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."

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