Women who have an aggressive form of advanced breast cancer gained a new option on Tuesday with the approval of a novel drug from GlaxoSmithKline.
The drug, Tykerb, is to a once-daily pill meant for women who have previously received treatment with Herceptin (a drug taken intravenously) and older chemotherapy drugs, called taxanes and anthracyclines. The Food and Drug Administration (FDA) said it approved Tykerb for use along with the chemotherapy drug Xeloda. The drug, which will be available by the end of March, will cost nearly $3,000 per month, or around $100 per pill.
The results of a study last year showed that the new drug, when taken along with Xeloda, delayed tumor growth for nearly 8 1/2 months. This is roughly twice as long as tumor growth is delayed in patients taking Xeloda only. Tykerb worked so well, in fact, that researchers called an early end to the study in order to offer all study participants the chance to take the drug. GlaxoSmithKline later said, however, that the delay was in reality closer to seven months for women on both Tykerb and Xeloda, versus close to five months for those only taking Xeloda.
The lack of information on whether women taking the combination of drugs will lead to longer lives has one advocacy group disappointed.
“The FDA should not approve drugs that have not shown either a survival benefit or improved quality of life for breast cancer patients with metastatic disease,” read a letter from Barbara Brenner, the executive director of Breast Cancer Action.
This is the first of four drugs GlaxoSmithKline hopes to gain FDA approval of by 2010. Tykerb is also being tested for other cancers, including early-stage and inflammatory breast cancers, as well as head and neck, gastric, and lung cancers.
Industry analysts say that widespread use of Tykerb could eventually make the new drug a massive money maker for GlaxoSmithKline, with potential annual sales approaching $1 billion. Because of the prohibitive cost, and uncertainty as to whether the treatment would be covered under existing health insurance policies, GlaxoSmithKline has announced that it will give Tykerb to patients with incomes less than $68,500 for free.
The most recent data available, from 2003, shows that slightly more than 180,000 women were diagnosed with breast cancer, and almost 42,000 died from it. Of those 42,000 women, between 8,000 and 10,000 die each year from HER-2 positive breast cancer, a more aggressive type which GlaxoSmithKline and the FDA hope their new drug will be successful in fighting.