The European Commission has given conditional marketing authorization for crizotinib (Xalkori?, Pfizer)in the European Union (EU) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This ALK gene abnormality causes cancer development and growth. About 1% to 7% of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer are typically non-smokers.

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

Similar to accelerated approvals in the United States, conditional marketing authorizations in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually.

Now that crizotinib has been granted a conditional marketing authorization, Pfizer will be required to submit data to the European Medicines Agency (EMA) from the recently completed PROFILE 1007 study, which was presented in September at the ESMO 2012 Congress in Vienna, Austria. The study met its primary endpoint in previously treated ALK-positive advanced NSCLC patients. Following review of the 1007 results by the EMA?s Committee for Medicinal Products for Human Use (CHMP), the European Commission will consider converting the conditional marketing authorization to a normal marketing authorization.

First in Class

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?Today?s approval is a significant milestone for adults with ALK-positive advanced NSCLC in Europe,? said Andreas Penk, M.D. president of Pfizer Oncology Europe. ?XALKORI is a first-in-class medicine and demonstrates Pfizer?s commitment to targeting specific molecular abnormalities and providing the right treatment to the right patient at the right time.?

Crizotinib is a first-in-classoral, anaplastic lymphoma kinase (ALK) inhibitor.[1] By inhibiting the ALK fusion protein, the drug blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells, which may lead to growth inhibition or regression of tumors.[2,3]The drug was first approved in the U.S. in August 2011 for the treatment of locally advanced or metastatic NSCLC that is ALK-positive as detected by a Food and Drug Administration (FDA)-approved companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kitdevelopped by Abbott. This indication is based on response rate. There are no data available demonstrating improvements in patient-reported outcomes or survival with crizotinib.

[1] Kwak E, Bang Y, Camidge R, et al. Anaplastic Lymphoma Kinase Inhibition in Non-Small Cell Lung Cancer. N Engl J Med.

[2]Chiarle R, Voena C, Ambrogio C, et al. The Anaplastic Lymphoma Kinase in the Pathogenesis of Cancer. Nat Rev Cancer.

[3] Zou HY, Li Q, Lee JH, et al. An Orally Available Small-Molecule Inhibitor of c-MET, PF-2341066, Exhibits Cytoreductive
Antitumor Efficacy through Antiproliferative and Antiangiogenic Mechanisms. Cancer Res. 2007;67:4408-4417.

[4] XALKORI Summary of Product Characteristics (SmPC) for the European Union.

For more information:

– Practice-changing Trial Results: Crizotinib Superior to Standard Chemotherapy in ALK-positive NSCLC – Onco’zine, October 1, 2012.

– ‘Smart drug’ Targets New Mutation And Dramatically Shrinks Aggressive Sarcoma And Lung Cancer – Onco’Zine, 27 October 2010

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