Pfizer files lung cancer drug in US and Japan
pharmafile | May 18, 2011 | News story | Sales and Marketing | NSCLC, Pfizer, crizotinib
Pfizer has submitted its oral lung cancer drug crizotinib for regulatory approval in the US and Japan.
Crizotinib is an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for advanced non-small cell lung cancer and has been granted priority review status by the US regulator the FDA.
This is given to drugs that offer major advances in treatment or may provide a treatment where no adequate therapy exists, and will cut its review time from 10 to six months – meaning it could be on the US market by November.
Crizotinib received orphan drug designation from the FDA in September 2010 and in January Pfizer initiated a ‘rolling submission’ of the drug, which allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis.
The drug has also been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW) who, like its US counterpart, granted crizotinib orphan drug status in January this year.
Pfizer said its submissions were the first simultaneous filings in Japan and the US from a non-Japanese pharma company.
Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit, said: “Our ability to file applications for regulatory review in the US and Japan simultaneously only three years after beginning worldwide clinical trials […] is a testament to the hard work of the crizotinib team and the productive discussions that we have had with the respective regulatory agencies.
“Given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced 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.
Crizotinib is being tested as a second and third line treatment for NSCLC patients expressing the ALK mutation, believed to be a key driver in tumour development. It is also in phase for previously untreated patients with ALK-positive NSCLC.
Currently, only 1-5% of NSCLC patients are thought to express the ALK mutation, but this may increase as gene testing continues.
Ben Adams
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