The European Commission has approved Roche’s Alecensa (alectinib) as a second-line therapy for patients with ALK-positive non-small cell lung cancer (NSCLC).
The regulatory authority’s decision was based on the results of two phase II studies, which showed that Alecensa shrank tumours in up to 52.2% of patients whose disease had progressed after treatment with Pfizer’s Xalkori (crizotinib), the current standard.
The monotherapy was also able to extend progression-free survival by up to 8.9 months in these patients, while 64% of patients whose disease had spread to parts of the central nervous system (CNS) saw measurable shrinkage of CNS tumours.
Alecensa has been available in the US since December 2015, when it won accelerated FDA approval as a second-line NSCLC therapy after being awarded breakthrough designation two months prior.
However, its licensing in the EU is conditional on the provision of further trial data on Alecensa’s clinical efficacy as a first-line treatment for ALK-positive NSCLC patients. Results from Roche’s ongoing phase III ALEX study comparing Alecensa and Xalkori are expected by June this year.
Dr Sandra Horning, 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.”