US FDA approves Glaxo drug for cervical cancer

WASHINGTON (Reuters) – GlaxoSmithKline Plc’s cancer drug
Hycamtin won U.S. approval on Thursday to treat late-stage
cervical cancer when used in combination with cisplatin in
cases when surgery or radiation is not likely to work.

The expanded indication also allows doctors to use the
combination as a first choice, after ruling out other options,
when the disease is incurable, recurrent or has spread to other
organs, the U.S. Food and Drug Administration said.

Hycamtin is already approved for ovarian and small call
lung cancer. Cisplatin is an injectable chemotherapy drug used
for various cancers, including ovarian, testicular and bladder.

Thursday’s approval 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 advanced clinical
trials that showed patients taking Hycamtin and cisplatin lived
9.4 months while those taking cisplatin alone lived 6.5 months.

Hycamtin can harm the immune system, lowering white blood
cell count 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.

Shares of Glaxo were off 57 cents, or 1 percent, at $53.82
in morning trade on the New York Stock Exchange.

(Additional reporting by Julie Steenhuysen in Chicago)