UPDATE 2-US FDA approves targeted Pfizer lung cancer drug

Fri Aug 26, 2011 7:00pm EDT

* FDA also approves Abbott companion diagnostic test

* Drug treats subset of non-small cell lung cancers

* Annual peak sales could reach $2.5 bln - analyst (Adds drug details, sales, price, company comment)

WASHINGTON, Aug 26 (Reuters) - U.S. regulators approved a genetically targeted lung cancer drug from Pfizer Inc (PFE.N), which is pushing into oncology medicines as its top-selling cholesterol fighter faces looming generic competition.

The U.S. Food and Drug Administration said on Friday it had approved Xalkori, along with a companion diagnostic test by a unit of Abbott Laboratories (ABT.N) that identifies which patients will benefit from the treatment.

Xalkori targets a small subset of patients with advanced non-small cell lung cancer with a specific genetic mutation, which translates to about 6,500 to 11,000 patients in the United States each year.

Pfizer has also applied for approval with the European Medicines Agency.

Xalkori could eventually reach annual peak sales of $2.5 billion, Morningstar analyst Damien Conover said in May. [ID:nN18299647]

Pfizer needs new products with its cholesterol fighting drug Lipitor, the world's top selling prescription medicine, set to lose U.S. patent protection late this year.

Xalkori will cost $9,600 a month, although the drugmaker said it has developed a program where eligible patients who have private insurance can get the drug for a $100 monthly co-pay.

"Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer," said Pfizer CEO Ian Read in a statement.

"Xalkori is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease."

The drug, known by the chemical name crizotinib, treats patients with advanced non-small cell lung cancer who express an abnormal anaplastic lymphoma kinase (ALK) gene, which is more common in nonsmokers.

The oral drug is from a new class of cancer medicines that block certain proteins produced by this type of gene, believed to be a driver of tumor development in certain cancers.

In one clinical trial for the drug, half of patients had their tumors shrink or disappear for an average of 42 weeks. In a second study, 61 percent of patients had that effect for an average of 48 weeks.

About four percent of lung cancer patients tend to be ALK positive, but about 10 percent to 15 percent of lung cancer patients who were never smokers fall into the category.

"Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects," said Dr. Richard Pazdur, head of the FDA's Office of Oncology Drug Products.

The drug's most common side effects were nausea, diarrhea, vomiting, swelling, constipation and vision disorders such as flashes of light or blurred vision.

The FDA granted the drug priority review, which means it is considered a potentially significant advance over existing therapies. It is the second targeted therapy the FDA approved this year, after Roche Holding's (ROG.VX) skin cancer drug Zelboraf. [ID:nN1E77G0BW] (Reporting by Anna Yukhananov; editing by Tim Dobbyn)

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