Roche: CHMP recommends approval for Alecensa.
(CercleFinance.com) - Roche announced on Friday that the EU's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
It has also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation.
The CHMP's recommendation about the first line treatment is based on results of the international phase III study ALEX, which has showed that Alecensa had significantly reduced (by 53%), the risk of a progression in the disease or death relative to crizotinib.
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It has also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation.
The CHMP's recommendation about the first line treatment is based on results of the international phase III study ALEX, which has showed that Alecensa had significantly reduced (by 53%), the risk of a progression in the disease or death relative to crizotinib.
Copyright (c) 2017 CercleFinance.com. All rights reserved.