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.