Winning the U.S. nod for breast cancer treatment Halaven is just Eisai's first step toward building up the drug. Now FDA-approved for late-stage breast cancer in women who've failed on at least two other treatments, the drug could reach $1 billion in annual sales, CEO Haruo Naito says, provided it wins additional indications.
Eisai is already developing Halaven for earlier use in breast cancer patients, Naito said at a Tokyo briefing. And as Reuters notes, other studies have shown that it may be effective at treating colon and urinary cancers. "The potential of the drug depends on whether it gets approval to be used as the first and second line of [breast cancer] treatment," Mitsubishi UFJ Morgan Stanley analyst Yasuhiro Nakazawa told Bloomberg.
In the meantime, as Bloomberg points out, the earlier-than-expected approval will allow Halaven to help make up sales lost to generic competition for Eisai's main drug, the Alzheimer's treatment Aricept. It will compete with Roche's Xeloda and Bristol-Myers Squibb's ($BMS) Ixempra. "Halaven shows a clear survival benefit and is an important new option for women," FDA's Richard Pazdur said in a statement.