Trials & Filings

Pfizer’s Xalkori Gains Full Approval

Breakthrough NSCLC drug confirms results

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has granted Pfizer‘s 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. Xalkori was previously granted accelerated approval in August 2011 due to the critical need for new agents for people living with ALK-positive NSCLC. To date, globally more than 6,000 patients have been treated with Xalkori, including those who received Xalkori in clinical trials. ALK testing r...

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