Step closer to European conditional approval for personalised drug
Pfizer's personalised lung cancer drug Xalkori (crizotinib) should be available for use in Europe according to the region's drug regulator.
The Committee for Medicinal Products for Human Use (CHMP) – part of the European Medicines Agency (EMA) – has given a positive opinion to grant Xalkori with conditional marketing authorisation for use in the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
The drug now just needs final approval from the European Commission (EC) before it is available under this conditional marketing approval, which is granted to help accelerate products that fulfil an unmet medical need to market despite a lack of available data.
If approved by the EC, Pfizer will be required to submit data to the EMA from the recently completed PROFILE 1007 study, which the company announced in June, 2012, met its primary endpoint.
Following review of these results by the CHMP, the EC would then consider converting the conditional marketing authorisation to a normal marketing authorisation.
“The CHMP's positive opinion brings us a step closer to potentially offering a new personalised treatment to patients with advanced NSCLC across Europe,” said Dr Mace Rothenberg, senior VP 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 programme on those patients.”
The oral drug works by inhibiting the ALK fusion protein, blocking the signalling ability of certain cell pathways thought to be crucial for the growth and survival of tumour cells to signal.
Clinical trials demonstrating that the drug achieved a median progression free survival of 9.2 months influenced the CHMP's positive recommendation, with the drug also achieving an objective response rate of 60 per cent in people who are ALK-positive.
As Xalkori is designed for a specific subset of patients with NSCLC, it is commonly referred to as a personalised or stratified medicine, and has been developed with a companion diagnostic to ensure potential patients are suitable for treatment.
A second simpler diagnostic tool is also in development following a deal between Pfizer, Roche subsidiary Ventana Medical Systems and Cell Signalling Technology in January, 2012.
Xalkori has been available in the US since August 2011.