FDA approves Glaxo drug for cervical cancer

By Susan Heavey

WASHINGTON (Reuters) – A new drug combination to treat
women with cervical cancer won U.S. approval on Thursday for
severe cases when surgery or radiation may not work.

The drug Hycamtin, sold by GlaxoSmithKline Plc, helped
patients live about three months longer when used with the
chemotherapy agent cisplatin than with cisplatin alone, the
U.S. Food and Drug Administration said.

Both drugs are already on the market and approved
separately to treat other cancers, including ovarian and lung.

That already allowed doctors to use the combination for
cervical cancer. The FDA’s ruling give the agency’s
stamp-of-approval and allows Glaxo to market the drug for the
expanded use.

The combination should be used after ruling out other
options when the disease is incurable, recurrent or has spread
to other organs, the agency said.

It is the second positive step in efforts to fight the
disease after the FDA last week approved Merck and Co. Inc.’s
vaccine for human papillomavirus, the leading cause of cervical
cancer.

Glaxo is developing its own HPV vaccine and expects to seek
U.S. approval later this year.

About 10,000 American women are diagnosed with the disease
each year and another 3,700 die, according to the FDA.

The agency said it based its decision on clinical data of
293 patients that showed those taking Hycamtin and cisplatin
lived an average of 9.4 months while those taking cisplatin
alone lived 6.5 months.

“This course of drug therapy is a potentially
life-prolonging option for thousands of women,” FDA Acting
Commissioner Andrew von Eschenbach said in a statement.

Hycamtin, which is given by infusion, can harm the immune
system, lowering white blood cell counts crucial to fighting
infections. The drug can also decrease blood platelets and lead
to excessive bleeding and anemia.

Nausea, vomiting, diarrhea and hair loss are also side
effects.

Considered a niche product for the British drugmaker,
Hycamtin is part of a class of anti-cancer drugs known as
topoisomerase I inhibitors that interrupt the replication of
DNA in cancer cells, causing them to die.

In contrast, analysts have said they expect Glaxo’s HPV
vaccine to reach potential blockbuster sales once approved.

Shares of Glaxo were off 31 cents, or less than 1 percent,
at $54.08 in midday trade on the New York Stock Exchange.

(Additional reporting by Julie Steenhuysen in Chicago)