21 February 2017
Roche has announced that the European Commission has granted a conditional marketing authorisation for Alecensa® (alectinib) as monotherapy for treating adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Within one year of treatment, most people with ALK-positive NSCLC develop resistance to the current standard of care, and approximately 60% develop metastases in the central nervous system (CNS).
Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, said: “Every year, an estimated 75,000 people are diagnosed with ALK-positive NSCLC worldwide. Development of resistance to the current standard of care underlines the need for alternative treatments. Today’s approval provides the promise of a new treatment option for people in Europe with this devastating disease.”
Under the provisions of the conditional approval, Roche will provide additional data on first-line Alecensa in ALK inhibitor naïve ALK-positive NSCLC patients from an ongoing phase III study ALEX, comparing Alecensa to crizotinib. The ALEX study is expected to report data in the first half of 2017.Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancerlast edit: 2017-02-22T18:04:11+00:00da