Pfizer’s Xalkori gains regular FDA approval for NSCLC

The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s (NYSE: PFE) Xalkori (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

The FDA previously granted Xalkori accelerated approval due to the critical need for new agents for people living with ALK-positive NSCLC who express the abnormal anaplastic lymphoma kinase (ALK) gene, along with a companion diagnostic (The Pharma Letter August 30, 2011).

The drug, which has been projected as having a $2 billion sales potential, is now approved in more than 60 countries, including European Union, Canada, China, South Korea, Japan and Australia. However, to date this year (first nine months) Xalkori generated sales of just $193 million).