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¾«¶«Ó°ÒµCorporation of North America

¾«¶«Ó°Òµ. (Headquarters: Tokyo, President & CEO: Haruo Naito) and Eisai's U.S. subsidiary, ¾«¶«Ó°ÒµCorporation of North America (Headquarters: New Jersey, the United States, Chairman & CEO: Hajime Shimizu), today announced a change in the schedule for submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for E7389 (generic name: eribulin mesylate) for third-line treatment of advanced breast cancer in patients who were pretreated with anthracycline, taxane and capecitabine.

¾«¶«Ó°Òµis committed to developing E7389 as a potential treatment for patients with advanced breast cancer. In a Phase Ⅱ study of 299 patients with advanced breast cancer who had been heavily pretreated, the compound has shown promising anti-tumor activity, with a response rate of 14.1% by investigator evaluation and 9.3% by independent radiologist evaluation. It has also been shown in the Phase Ⅱ study to be generally well-tolerated, with the most common Grades 3 and 4 drug-related adverse events being 54% in neutropenia and, 14% in leucopenia. Grade 3 peripheral neuropathy occurred in 6% of study participants, and there were no Grade 4 events.

¾«¶«Ó°Òµhad 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 last October. ¾«¶«Ó°Òµremains committed to advancing two Phase Ⅲ clinical trials for E7389, which are ongoing in the U.S. and in Europe, Study 301 for second-line and Study 305 for third-line breast cancer treatment. ¾«¶«Ó°Òµnow 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, ¾«¶«Ó°Òµcontinues to evaluate E7389 as a potential treatment for a variety of other solid tumors, including non-small cell lung cancer, prostate cancer and sarcoma.

E7389 is a novel compound developed by ¾«¶«Ó°Òµas a new potential anti-cancer agent that suppresses the growth of microtubule which is involved in various cellular processes in the body, such as cell division. E7389 is a synthetic analog of halichondrin B, a naturally-occurring compound which was first isolated from a type of marine sponge in 1992.

¾«¶«Ó°Òµhas a strong commitment to the development of new oncology medicines to address the unmet medical needs of patients with cancer. Currently, seven other ¾«¶«Ó°Òµoncology compounds are in clinical development, in addition to E7389.