A study being published in a major medical journal confirms the promise of a breast cancer drug from GlaxoSmithKline that's awaiting the approval of the Food and Drug Administration, CNBC's Mike Huckman reports.
Researchers report in the new issue of the New England Journal of Medicine that the pill, called Tykerb (pronounced tie-curb), halved the risk of cancer progressing and nearly doubled the time to when tumors started to grow again.
The drug is designed for women who have an aggressive form of breast cancer and who are no longer responding to Genentech's Herceptin. But for the first time, the researchers say tests should be done using Tykerb in earlier stages of the disease.
Glaxo hopes to win FDA approval of the drug early next year.
Metastatic breast cancer is the number-one killer among cancers affecting women worldwide, accounting for more than 400,000 deaths a year.
Separately, Glaxo's anti-nausea drug Zofran will face competition from at least four generic versions recently approved by the Food and Drug Administration, after the company's patent expired.
Zofran had sales of $1.6 billion last year, driven by a 12% sales increase in the U.S, according to GlaxoSmithKline. The drug is given to cancer patients receiving chemotherapy to prevent vomiting.
In 2005, Zofran was the 20th best selling drug in the U.S. with sales of $839 million, according to figures cited by the FDA.
The agency said Wednesday it granted Indian drug company Dr. Reddy's Laboratories approval to market generic tablets of ondansetron, the active ingredient in Zofran. Teva Pharmaceutical Industries, Hospira and Par Pharmaceuticals previously announced they also have received FDA approval to market generic versions of Zofran.
Several GlaxoSmithKline drugs are scheduled to lose patent protection over the next two years. Earlier in December, the FDA approved Anchen Pharmaceuticals's application to market a generic version of the blockbuster Wellbutrin, sold by GlaxoSmithKline for developer Biovail. Other GlaxoSmithKline drugs scheduled to lose patent protection before the end of 2008 include bipolar disorder drug Lamictal, high blood pressure drug Coreg, and migraine medication