CHMP recommends change of approval of Alecensa (alectinib) in non-small cell lung cancer.- Roche.

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Alecensa (alectinib), from Roche, in non-small cell lung cancer. In addition, since all specific obligations of the conditional marketing authorisation have been fulfilled, the marketing authorisation for Alecensa will be switched from conditional to full approval.

The CHMP adopted an extension to the existing indication as follows: Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Alecensa as monotherapy is indicated for the treatment of adult patients with ALK)-positive advanced NSCLC previously treated with crizotinib".

Comment: Alecensa is approved as a monotherapy for patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Thailand and Taiwan. Alecensa is also approved in Japan for patients whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable). In the United States, Alecensa was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.