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Home Industry News Eisai files for approval of expanded Halaven indication in Europe

Eisai files for approval of expanded Halaven indication in Europe

7th May 2013

Eisai has filed an application with the European Medicines Agency for an expanded indication for its approved anticancer agent Halaven.

The company is seeking ratification for the drug as a means of contributing to earlier-line treatment of patients with metastatic breast cancer, based on data from clinical trials that supports this new indication.

Halaven is the first and only single-agent chemotherapy agent in the world to statistically and significantly extend overall survival rates compared to the current standard of care among metastatic breast cancer sufferers – a group that currently lacks a range of treatment options.

Currently, its usage is limited to patients who have previously received at least two chemotherapeutic regimens, a situation Eisai hopes to change with its latest application.

"Eisai remains committed to providing scientific evidence aimed at maximising the value of Halaven," the company said.

Last month, the firm announced an alliance with GE Healthcare that will see the companies collaborating on a trial for a promising new therapy for Alzheimer's disease.ADNFCR-8000103-ID-801581632-ADNFCR

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