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30 Aug 2011

FDA Approves Pfizer's Lung Cancer Therapy

Pfizer announced that it received US approval for its lung cancer drug Xalkori.

Pfizer announced last week its FDA approval for Xalkori (crizotinib) capsules, the first therapy designed to target anaplastic lymphoma kinase (ALK), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).


The effectiveness of Xalkori is based on objective response rates (ORR) using a targeted approach in the registration trials. ORR of 50% and 61% were observed in patients with advanced ALK-positive NSCLC.


Pfizer worked closely with the FDA and partnered with Abbott’s Molecular business for the clinical studies to help ensure the simultaneous review and approval of Xalkori along with the diagnostic test.


Abbott received app

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