European regulators have given the go-ahead to Roche's Alecensa as a treatment for people with previously treated ALK-positive non-small cell lung cancer (NSCLC).
The European Commission has granted a conditional marketing approval for the drug as monotherapy for the treatment of adult patients with the disease who have previously been treated with crizotinib.
Underlining the need for new treatments for this patient group, Roche said most people with ALK-positive NSCLC develop resistance to the current standard of care within one year of treatment, and around 60 percent will develop metastases in the central nervous system.
The decision is based primarily on data from the pivotal Phase II NP28673 and NP28761 studies, which showed that Alecensa (alectinib) shrank tumours in up to 52.2 percent of people with advanced ALK-positive NSCLC whose disease had progressed following treatment with crizotinib.
The studies also showed that Alecensa extended progression-free survival by up to 8.9 months, while a pooled analysis of the data showed that the drug shrank CNS tumours that were measurable in 64 percent of patients and 22 percent achieved a complete response of their measurable and non-measurable CNS tumours.
Conditional approval is issued when a medicine fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. As such, Roche will need to 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, which is expected to report data in the first half of 2017.
Around 75,000 people are diagnosed with ALK-positive NSCLC worldwide every year.
Alecensa is already approved for ALK-positive NSCLC in eight countries in the crizotinib failure setting, and also in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery.