• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

US FDA approves Glaxo drug for cervical cancer

Posted on: Thursday, 15 June 2006, 10:19 CDT

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)

Source: REUTERS

More News in this Category