Jul 21 2012
Pfizer announced today that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending that crizotinib be granted conditional
marketing authorization 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).
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. If
crizotinib is granted conditional marketing authorization, Pfizer will
be required to submit data to the EMA from the recently completed
PROFILE 1007 study, which the company announced in June met its primary
endpoint in previously treated ALK-positive advanced NSCLC patients.
Following review of the 1007 results by CHMP, the European Commission
would then consider converting the conditional marketing authorization
to a normal marketing authorization.
"The CHMP's positive opinion brings us a step closer to potentially
offering a new personalized treatment to patients with advanced NSCLC
across Europe," said Mace Rothenberg, MD, senior vice president of the
clinical development and medical affairs for Pfizer's Oncology Business
Unit. "This achievement is made possible by our commitment to using
knowledge of the underlying genetic drivers of diseases to identify
patients most likely to benefit from treatment and to focus our clinical
development program on those patients."
The CHMP's positive opinion will be reviewed by the European Commission,
which has the authority to approve medicines for the European Union.
Pfizer anticipates a decision from the Commission in the coming months.
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