Lung cancerThe European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Zykadia (ceritinib).

Zykadia is recommended for the treatment of adults with a type of lung cancer called anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), when the disease is advanced and has already been treated with crizotinib.

Lung cancer is among the most common cancers in the world. Some 85% of all lung cancers are NSCLC. Most patients with NSCLC are found to have advanced disease at the time of diagnosis. Patients with locally advanced or metastatic NSCLC are generally treated with standard chemotherapy and/or radiation, but survival rates are poor.

In a small proportion (2-7%) of people with NSCLC, the cancer cells contain defects in the gene responsible for a protein called anaplastic lymphoma kinase (ALK), which promotes the development of cancerous cells. People with this type of cancer are said to have ‘ALK-positive’ NSCLC.

Crizotinib is the only approved medicine for the treatment of previously treated locally advanced or metastatic ALK-positive NSCLC. However, even with treatment, disease progression typically occurs. Furthermore, not all patients respond to crizotinib treatment.

The Committee for Medicinal Products for Human Use (CHMP) considered that Zykadia provides a treatment option for a high unmet medical need in patients previously treated with crizotinib, as treatment options are currently very limited.