EU CHMP recommends change to indication for Xalkori (crizotinib) in NSCLC- Pfizer

The EU's Committee for Medicinal Products for Human Use has recommended a change to the marketing authorisation for Xalkori (crizotinib), from Pfizer. This recommends it is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Comment: Alterations in the ALK gene are believed to be a key driver of tumour development in cancers like NSCLC. The presence of the ALK fusion gene in lung cancer was first reported by a Japanese researcher in 2007. Preliminary epidemiology suggests that approximately 3–5% of NSCLC patients have tumours that are positive for the ALK fusion gene. By inhibiting ALK, crizotinib blocks signalling in a number of cell pathways that are believed to be critical for the growth and survival of tumour cells.