Roche receives EU approval for lung cancer drug Alecensa

Roche has announced that its new lung cancer therapy Alecensa has been approved by the European Commission.

The regulator has issued a conditional marketing authorisation for Alecensa as a monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

This decision was based primarily on data from the pivotal phase II NP28673 and NP28761 studies, which showed the effectiveness of Alecensa in shrinking tumours among patients whose disease had progressed following treatment with crizotinib. It was also showed that the drug was able to extend progression-free survival by up to 8.9 months.

Conditional approval is granted to products that address an unmet medical need, meaning the benefit of immediate availability outweighs the risk of less comprehensive data than would normally be required. 

Most people with this form of NSCLC develop resistance to the current standard therapy within one year of treatment, while approximately 60 percent develop metastases in the central nervous system.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "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."

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