Pfizer lung cancer drug gets ‘rolling’ fast-track status in US
pharmafile | January 13, 2011 | News story | Sales and Marketing | Cancer, NSCLC, axitinib, bosutinib, crizotinib, non-small cell lung cancer
Pfizer has initiated a ‘rolling’ submission for its new oral ALK lung cancer drug crizotinib that could see it on the market in early 2012.
Crizotinib is being tested as a second and third line treatment for non-small cell lung cancer (NSCLC) patients expressing the anaplastic lymphoma kinase (ALK) mutation, believed to be a key driver in tumour development.
Currently, only 1-5% of NSCLC patients are thought to express the ALK mutation, but this may increase as gene testing continues.
The FDA’s fast-track process is granted to drugs that demonstrate the potential to address unmet medical need for a serious or life-threatening disease and this was given to Pfizer’s drug in December.
The rolling submission, which is available to medicines that have received fast-track designation, allows completed portions of their new drug application to be submitted and reviewed by the FDA on an ongoing basis.
Garry Nicholson, president and general manager of Pfizer oncology business unit, said: “This action represents a significant step in the registration process for crizotinib.
“Pfizer is committed to working collaboratively with the FDA as we move forward in the submission process with the ultimate goal of offering a new treatment option for patients with advanced ALK-positive NSCLC.”
There are currently no drugs for ALK mutations for NSCLC patients and this submission could help build up the arsenal against what is now a plurality of diseases.
The biggest proportion of known NSCLC mutations is from EGFR (epidermal growth factor receptor), which is targeted by AstraZeneca’s Iressa.
NSCLC remains as the biggest cancer killer globally with the average patient living only eight months after diagnosis.
Pfizer said in a statement that it expects to complete submission of crizotinib in the first half of 2011 and couple with its fast track review status this could see it on the market in early 2012 if it is approved.
In preparation for this Pfizer has plans to run a national public awareness campaign for personalised medicine in oncology.
Pfizer plans two more oncology drug submissions
Pfizer also plans to submit two other investigational oncology compounds to European and US regulators in 2011.
Axitinib is an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3 that treats metastatic renal cell carcinoma, and bosutinib is an oral dual SRC and ABL kinase inhibitor for the treatment of chronic myeloid leukaemia.
Part of Pfizer’s plans to offset the impact of its biggest seller Lipitor going off patent in November have involved re-focusing its pipeline to build up a strong oncology portfolio.
Ben Adams
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