Clapper, Patti, Schweizer and Mason

Pfizer, a worldwide leader in the pharmaceutical industry, has developed a new anti-cancer drug that specifically targets non-small cell lung cancers such as mesothelioma.  The drug is one step closer to full-scale distribution, which may bring hope to the nearly 3,000 Americans diagnosed with mesothelioma each year. 

In an official announcement from the U.S. Food and Drug Administration, Xalkori was approved in addition to the companion diagnostic test designed and supervised by a division of Abbott Laboratories.  The drug and the test go hand-in-hand.  The test was specifically created to find patients who would respond the best to the new drug before therapy ever begins.

The drug was approved earlier by the European Medicines Agency (EMA), which is the equivalent to the FDA in the United States. 

The new drug was granted a priority review which means that experts at the FDA consider the drug to be leaps and bounds ahead of other similar therapies already available.

Xalkori is unique in that it specifically targets patients with a rare form of non-small cell lung cancer.  The specific cancer corresponds to a unique genetic mutation and effects an estimated 6,500 to 11,000 people in the United States Alone.

The company targeted lung cancer for two reasons: 1) "Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer," said Pfizer CEO Ian Read, and 2) because the company needs to find new drugs to create new revenue as with each passing year more and more of their patents expire and generic versions of their drugs become available.

The drug is administered orally and blocks certain proteins which are believed to be essential in the growth cycle of cancer cells.  Thus the drug essentially starves the tumor and doesn’t allow it to progress.  In the pre-release clinical trials up to 50% of patients saw tumors shrink or disappear altogether for an average of 45 weeks.

While the drug is currently only approved to treat a very specific type of lung cancer, its use may expand after it has been on the market for some time.  This “off-label use” is common in the pharmaceutical industry.  And even if the drug is only ever used to treat this small subset of cancer patients, the data that Pfizer collects from studying the effects of Xalkori (both on the cancer and on the patients themselves) may hold the key to developing therapies to treat other types of lung cancer such as mesothelioma.