Pfizer receives CHMP recommendation for lung cancer drug
23 July 2012 11:26 in Pharmaceutical Company Product News
Pfizer has been granted a recommendation for European approval of crizotinib as a treatment for non-small cell lung cancer (NSCLC).
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug for use among adults with previously treated anaplastic lymphoma kinase-positive advanced NSCLC.
This conditional marketing authorisation recommendation is contingent on the submission of data from the recently completed phase III study Profile 1007, from which positive results have already emerged.
Following this, the European Commission will conduct a full review of the drug to decide whether it will be approved for EU marketing.
Dr Mace Rothenberg, senior vice-president of clinical development and medical affairs for Pfizer's oncology business unit, said: "The CHMP's positive opinion brings us a step closer to potentially offering a new personalised treatment to patients with advanced NSCLC across Europe."
This comes after the company's new therapy for postmenopausal women, bazedoxifene/conjugated oestrogens, was accepted for European review earlier this month.
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