Eisai’s NDA For Anti-Cancer Drug Accepted By China FDA
The China Food and Drug Administration (CFDA) has accepted a new drug application (NDA) submitted by Eisai for the company's anti-cancer agent, Halaven (eribulin mesylate), for treating patients with locally advanced or metastatic breast cancer in China.
The drug was first approved in the US in November 2010 for use in the treatment of breast cancer. Halaven is currently approved in over 60 countries, including Japan and countries in Europe, the Americas, and Asia. The drug had 2015 global sales of JPY 40,168 million ($394 million).
Halaven is a halichondrin-class microtubule-dynamics inhibitor that has been associated with increased vascular perfusion and permeability in tumor cores.