29 September 2015 - Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai's in-house developed anticancer agent Halaven (eribulin mesylate) as a treatment for soft tissue sarcoma, and granted the sNDA Priority Review status.

The FDA's Priority Review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of January 29, 2016, six months after the sNDA was submitted.

Eisai submitted applications seeking approval for the additional indication of soft tissue sarcoma in the United States and Europe (EU) respectively on July 29, 2015, and in Japan on July 30, 2015.

For more details, go to: http://www.eisai.com/news/news201565.html