* 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
NEW YORK, May 17 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
Pfizer is seeking approval for crizotinib for the treatment
of patients with a certain form of advanced non-small cell lung
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
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)