Conditional European approval for Pfizer's Xalkori

The European Commission yesterday gave conditional marketing authorization for global drugs behemoth Pfizer’s (NYSE: PFE) Xalkori (crizotinib) in the European Union for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Analysts predict Xalkori, which was approved by the US Food and drug Administration last year (The Pharma Letter August 30, 2011), could be a blockbuster product for Pfizer, eventually reaping more than $2 billion in annual sales by 2021.

“In the field of metastatic non-small cell lung cancer, Xalkori represents a major advancement. It brings to the patients with ALK-translocated tumors an oral compound that can achieve tumor shrinkage and delay disease progression,” said Jean-Charles Soria, professor of Medicine and Medical Oncology at South-Paris University and cancer specialist at Institut Gustave Roussy, France, quoted by Pfizer.