Roche’s Alecensa receives CHMP backing for EU lung cancer approval

Roche has announced that its drug Alecensa has been recommended for European approval in a new lung cancer indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Alecensa in the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib.

Data from the pivotal studies NP28673 and NP28761 showed that Alecensa was an effective tumour reduction method in these patients, helping to deliver survival rate benefits as a result.

Based on this positive CHMP recommendation, a final decision regarding a conditional marketing authorisation is expected from the European Commission in the next few months.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "Today's positive CHMP opinion is great news for people living with ALK-positive NSCLC and brings us one step closer to providing a much needed new treatment option for people and physicians in Europe."

This form of cancer occurs in approximately five percent of people with advanced NSCLC and is more common in light or non-smokers.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.