The European Commission has granted conditional marketing authorization for Pfizer's Xalkori (crizotinib) 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).
“In the field of metastatic non-small cell lung cancer, Xalkori represents a major advancement. It brings to the patients with ALK-translocated tumours an oral compound that can achieve tumour shrinkage and delay disease progression,” said Dr. Jean-Charles Soria, 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 Xalkori 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.
“Today’s approval is a significant milestone for adults with ALK-positive advanced NSCLC in Europe,” said Dr. Andreas Penk, 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.”
Xalkori is an oral, anaplastic lymphoma kinase (ALK) inhibitor. By inhibiting the ALK fusion protein, Xalkori blocks signalling in a number of cell pathways that are believed to be critical for the growth and survival of tumour cells, which may lead to growth inhibition or regression of tumours.
Xalkori is a first-in-class medicine that has received conditional marketing authorization in Europe. Xalkori was first approved in the US 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 test. This indication is based on response rate. There are no data available demonstrating improvements in patient-reported outcomes or survival with Xalkori. Xalkori also has received approval in a number of other countries, including Switzerland, Canada, South Korea and Japan. Additional applications are under regulatory review in several countries worldwide.