Alecensa alectinib regulatory update

Japan’s Ministry of Health, Labor and Welfare (MHLW) approved an NDA from Chugai for Alecensa alectinib to treat unresectable, recurrent or advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Chugai, which is majority owned by Roche, will launch the ALK inhibitor in the country later this year. Japan is the first country to approve the product. The application was based on data from a Japanese Phase I/II trial. Chugai discovered the compound and is developing it in Japan. Roche has rights to the compound elsewhere. ...