Japan's Eisai has picked up a key regulatory win at the FDA, gaining approval to start selling a new breast cancer drug as a third-line therapy just as its big Alzheimer's drug--Aricept--rolls off patent in a little more than a week.
Halaven (eribulin mesylate) will be available for metastatic breast cancer victims who have already failed two chemotherapies. And the Japanese pharma company is targeting a blockbuster $1 billion in annual revenue, notes Bloomberg, as it hustles to gain new approvals that will permit the drug's use as a second- or even first-line therapy.
This is Eisai's first new approval of an original drug in more than a decade. Researchers developed a synthetic copy of a chemical originally found in sea sponges. It will compete with Xeloda from Roche and Ixempra from Bristol-Myers Squibb ($BMY).
"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."
"Many women with metastatic breast cancer see their disease progress after receiving multiple therapies," said Linda Vahdat, a professor of medicine at New York-Presbyterian Hospital/Weill Cornell Medical Center. "Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease."
- read the FDA release
- and here's the Eisai release
- see the report from Bloomberg