The drug’s earlier indication was for the second-line treatment of NSCLC. The data supporting the expanded label was generated by the Phase 3 Profile 1014 study.
The study demonstrated that Xalkori prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.
Pfizer regional president of oncology for Europe, Africa and the Middle East, head of Greater China and Asia-Pacific oncology regions Andreas Penk said: "The European Commission’s decision to approve Xalkori in the first-line setting reinforces Xalkori’s role as a standard of care for patients with ALK-positive advanced NSCLC."
Xalkori blocks signaling in several cell pathways that are believed to be important for the growth and survival of tumor cells, which may result in growth inhibition or regression of tumors.
It was the first ALK inhibitor cleared in the US, EU, China, and Japan. It is commercially available in over 85 countries.
NSCLC accounts for about 85% of lung cancer cases and around 57% of NSCLC patients are diagnosed late with metastatic, or advanced, disease where the five-year survival rate is just 5%.