Regulatory Guidance

Eisai Thyroid Cancer Drug Wins FDA Approval; Drugmaker Seeks More Indications, Blockbuster Status

Source: Wall Street Journal

Feb 17, 2015

The U.S. FDA has approved Tokyo-based Eisai's drug to treat the most common form of thyroid cancer.

The drug, Lenvima, was cleared for use in patients with progressive, differentiated thyroid cancer (DTC) who have not adequately responded to radioactive iodine therapy

Lenvima was granted FDA "orphan drug status" and was evaluated by the agency under its priority review program.

According to the WSJ, Eisai plans to seek U.S. approval for the drug in liver-cancer patients by March 2017. A kidney-cancer filing is also on teh horizon. With these additional indications, they drugmaker expects Lenvima to reach blockbuster status by 2020.

Read the WSJ article