Please login to the form below

Not currently logged in
Email:
Password:

CHMP backs Pfizer’s lung cancer drug Xalkori for use in Europe

Step closer to European conditional approval for personalised drug

Pfizer Xalkori lung cancer

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.

23rd July 2012

Share

Related Hub content

    Your search did not contain any words. Please try again.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
eyeforpharma

eyeforpharma is a hub for senior-level pharma executives, patient advocacy groups and other health experts to exchange ideas and stay...

Latest intelligence

Easier access to medicines in the UK?
Cutting through the NICE value-based assessment consultation to find out what’s at stake...
Exploring MINT: Part 3 - Nigeria
In the third of a series of posts focusing on each of the ‘MINT’ markets, I take an in-depth look at the opportunities and challenges for pharma in Nigeria....
BL_Where_Now_20140721_CoverImage.jpg
3 Steps to Navigating Multichannel in Healthcare
You know about multichannel, but... where now? Download the 3 Steps to Navigating Multichannel in Healthcare ebook to learn what you should do next when planning your multichannel campaign....