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Home Industry News Eisai Limited submits new cancer drug for European approval

Eisai Limited submits new cancer drug for European approval

31st March 2010

Eisai Limited has applied for European regulatory approval of eribulin mesylate, its new treatment for sufferers of locally advanced or metastatic breast cancer.

The treatment, which is based on a chemical compound discovered and developed by Eisai, has been submitted to the European Medicines Agency after showing strong potential in clinical trials.

A phase III study of the drug showed that it offered statistically significant improvements to survival rates when compared to a variety of alternative treatments, while earlier phase II studies also yielded positive results.

The drug has also been submitted for approval by healthcare regulators in both Japan and the US.

Eisai said: “Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits to patients and families affected by cancer as well as healthcare professionals.”

Earlier this month, the company was given clearance by an independent data monitoring committee to proceed with a clinical trial of its new eritoran endotoxin treatment for sepsis after providing safety and efficacy data.

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