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news.Eisai has announced a change in the schedule for submission to the FDA of a new drug application for E7389 for third-line treatment of advanced breast cancer, in patients who were pretreated with anthracycline, taxane and capecitabine.
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Eisai had planned to submit an NDA under Subpart H, based on Phase II clinical trial data, to seek accelerated approval for E7389 as a third-line breast cancer treatment (monotherapy), but is precluded from doing so, because FDA approved another drug for this specific indication in October, 2007.
Eisai remains committed to advancing two Phase III clinical trials for E7389, which are ongoing in the US and in Europe, Study 301 for second-line and Study 305 for third-line breast cancer treatment. Eisai now plans to submit an NDA to FDA with data from these trials and Phase II clinical trial data in fiscal year 2009-2010. In addition, Eisai continues to evaluate E7389 as a potential treatment for a variety of other solid tumors, including non-small cell lung cancer, prostate cancer and sarcoma.