Pfizer announced Tuesday that the FDA accepted the company's filing seeking approval of crizotinib for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumours are ALK-positive, and also granted the application priority status. The drugmaker additionally noted that a marketing submission for the compound was submitted in Japan.


Garry Nicholson, general manager of Pfizer's oncology unit, commented that "given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced NSCLC."


Data published last year showed that in a Phase I trial of 82 patients with NSCLC who had a mutation of the ALK gene, 57 percent had a significant reduction in tumour size after receiving twice-daily crizotinib. The drug also led to a disease control rate of 87 percent. According to the company, around 3 percent to 5 percent of people with NSCLC have tumours that are positive for the ALK fusion gene.
 

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