EU expands indication of Xalkori (crizotinib) to include previously untreated patients with ALK-positive NSCLC- Pfizer

The European Commission has approved a label update to expand use of Xalkori (crizotinib), from Pfizer, to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The Summary of Product Characteristics also has been updated to include efficacy data from PROFILE 1014, which demonstrated that Xalkori significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.

The European Commission’s approval of Xalkori follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by the results from PROFILE 1014, a Phase 3 global, randomized, open-label, two-arm study evaluating the efficacy and safety of Xalkori in patients previously untreated for ALK-positive advanced nonsquamous NSCLC.

Comment: Alterations in the ALK gene are believed to be a key driver of tumor development in cancers like NSCLC. Epidemiology suggests that approximately 3–5 percent of NSCLC patients have tumors that are positive for the ALK fusion gene. By inhibiting ALK, crizotinib blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells.