Pfizer receives conditional marketing authorisation from the European Commission for XALKORI.
M2 PHARMA-October 25, 2012-Pfizer receives conditional marketing authorisation from the European Commission for XALKORI(C)2012 M2 COMMUNICATIONS
Healthcare company Pfizer Inc (NYSE:PFE) said on Wednesday that the European Commission has given conditional marketing authorisation for 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).
Conditional marketing authorisations in the EU, similar to accelerated approvals in the US, 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 authorisation is renewable annually.
With the grant of conditional marketing authorisation for XALKORI, 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 2012 at the ESMO 2012 Congress in Vienna, Austria.
The company said that the PROFILE 1007 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 authorisation to a normal marketing authorization.
XALKORI is an oral, anaplastic lymphoma kinase (ALK) inhibitor.
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|Date:||Oct 25, 2012|
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