FDA gives green signal for Glaxo's new breast cancer drug

GlaxoSmithKline Plc on Tuesday won US approval for its once-a-day breast cancer pill Tykerb, that the drug maker hopes would give oncologists a new treatment option and will launch a new era for its oncology business as well.

The U.S. Food and Drug Administration yesterday gave its node to sell Tykerb for breast cancer, the most common cancer among women striking about 1 million women a year worldwide.

The health agency cleared the drug for patients with advanced breast cancer in combination with Roche Holding's oral chemotherapy drug, Xeloda, or capecitabine.

For now, the US regulators approved the Tykerb plus chemotherapy only for treatment of advanced breast cancer in women who carry the HER-2 gene and who no longer respond to Roche's Herceptin and Genentech Inc's rival product.

Tykerb that costs $2,900 a month, around 10 percent less than Herceptin, belongs to a class of drugs known as dual- kinase inhibitors, which impede the growth of tumor cells.

"New targeted therapies such as Tykerb are helping expand options for patients," said Dr. Steven Galson, head of the FDA`s Center for Drug Evaluation and Research.

Tykerb or lapatinib, is the first of four cancer drugs that London-based GlaxoSmithKline hopes to get approved by 2010.

In a late-stage trial in June, US researchers included 324 women and treated them with a Tykerb/Xeloda combo. After examining the medical data, they found that it took 8.4 months until their advanced or metastatic breast cancer progressed, compared with 4.4 months in women given Xeloda alone.

Other trials to find out Tykerb’s capability to treat early-stage and inflammatory breast cancers, as well as head/neck, gastric and lung cancers, are also underway.

Glaxo, the world's second largest drugmaker after Pfizer, is planning to introduce five new treatments this year.

Glaxo asserts that the approval for Tykerb will help in generating revenues, helping it counter laggard growth in sales of its top-selling asthma drug Advair and the loss of patent protection on other products.

Market analysts estimate that Tykerb will bring in $258 million for Glaxo in the U.S. by 2010 and $1.1 billion by 2015. In 2006, Glaxo posted sales of $45.5 billion, about half of which came from the U.S.

Tykerb may face stiff competition from rival Herceptin, which is given in monthly infusions and brought in $3.16 billion for Roche last year.

The British drug manufacturer also intends to grab a bigger share of the $35 billion global cancer market currently dominated by Roche and Genentech Inc.

Glaxo has announced that it will offer Tykerb for free to low-income US citizens without health insurance and even those patients who have enrolled themselves in the Medicare plan for the elderly and disabled, and spend $600 a year on other drugs will also be eligible to get the drug free.

According to the American Cancer Society estimates, nearly 212,920 new cases of the disease were diagnosed in the U.S. in 2006, while over 360,000 new cases of breast cancer are diagnosed in Europe every year.

Nearly 8,000 to 10,000 women die from the HER-2 positive form of breast cancer each year, FDA said. HER-2 positive breast cancer is a more aggressive disease in which the human epidermal growth factor receptor 2 is over-expressed, FDA says.

Glaxo shares close down 75 cents or 1.3 percent, at $55.25 in New York Stock Exchange composite trading, while Genentech rose 1 cent to $81.27 in after-hours trading, following a close of $81.30 on the NYSE. Roche's stock slid 2 percent.