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UPDATE 2-Pfizer lung cancer drug to get speedy U.S. review
May 17, 2011 / 11:31 AM / 6 years ago

UPDATE 2-Pfizer lung cancer drug to get speedy U.S. review

* Pfizer expects U.S. decision this year

* Says also filed seeking approval in Japan

* Shares up 1 percent (Adds approval expected this year, share price, kidney cancer drug filing)

NEW YORK, May 17 (Reuters) - Pfizer Inc’s (PFE.N) experimental lung cancer drug will be reviewed on a priority basis by U.S. health regulators and could be approved this year, the drugmaker said on Tuesday.

The drug, crizotinib, is one of the most important medicines in the late-stage developmental pipeline for Pfizer, the world’s largest drugmaker, which is increasingly pushing into oncology.

Pfizer is seeking approval for crizotinib for the treatment of patients with a certain form of advanced non-small cell lung cancer.

By granting priority review, the Food and Drug Administration will accelerate the review period to a goal of six months as opposed to the usual 10 to 12 months. Such reviews are given to products considered to be potentially significant therapeutic advances over existing therapies.

Pfizer declined to disclose the specific action date for an FDA decision but said the company expects approval by the end of this year.

That could come right about the time Pfizer’s cholesterol fighter Lipitor, the world’s top-selling medicine, is expected to begin facing competition from cheaper generics, underscoring the company’s need for new products.

Pfizer also said on Tuesday that it filed a crizotinib application seeking approval from Japanese regulators.

The company expects later this year to file an application seeking U.S. approval for its experimental kidney cancer drug axitinib.

Crizotinib is an oral drug from a new class of cancer medicines that inhibits a gene called anaplastic lymphoma kinase, or ALK. Alterations of ALK are believed to be a driver of tumor development in certain cancers.

Pfizer shares were up 22 cents, or 1 percent, at $21.20 in afternoon trading on the New York Stock Exchange. (Reporting by Lewis Krauskopf and Bill Berkrot; Editing by Derek Caney and John Wallace)

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