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Posts with tag nexavar

Trials of Nexavar liver cancer drug stopped early

Nexavar, a pharmaceutical drug designed to treat liver cancer, had a late-stage trial recently cut off and disbanded.

But, the reason is not what you think: the trial was ended because the results of patients using the drug were all so positive that a further continuation of the trial was not needed.

The trial (which was classified "Phase III" -- the 'final' stage) was conducted on over 200 patients in China, Korea and Taiwan. All patients took Nexavar and all were suffering from hepatocellular carcinoma -- the most common liver cancer.

Still, it's odd that any trials were ended due to excellent results. Even if that is so, shouldn't all drugs complete a start-to-finish trial period, regardless of success rate?

FDA gives stamp of approval for kidney cancer drug

New cancer drug Torisol was approved on Wednesday by the FDA for use with renal cell carcinoma, an advanced form of kidney cancer.

Torisol, also known as temsirolimus, is an enzyme inhibitor made by Wyeth Pharmaceuticals and has shown promise for prolonging patient survival. It's the third kidney cancer drug approved in the past 18 months -- the other two are Nexavar, intended to delay disease progression, and Sutent, for tumor size reduction.

Many kidney cancer patients are cured by surgery. About 35 percent of patients, however, experience a recurrence or a spread of the disease. Until just recently, there were no effective drugs to control these issues. Now there are several -- and Torisol is the one showing modest improvement in survival for patients with the most advanced tumors. Further study will indicate whether or not the drug is useful for patients with less extensive metastatic disease.

FDA needs more time with Wyeth kidney cancer drug

The Food and Drug Administration (FDA) will take an additional three months to review Wyeth's kidney cancer drug Torisel -- the first of five new medications the company plans to introduce this year.

The FDA needs more time to investigate data on tumor growth in patients taking Torisel. If all goes well, the drug will be one of only three to effectively hold off incurable kidney cancer. The other two drugs are Pfizer's Sutent and Bayer AG's Nexavar.

Robert Ruffolo, president of Wyeth Research, says he is encouraged by the review process so far. And he is optimistic about launching the product in late 2007.

Studies show Torisel, which will cost patients about $30,000 per year, prolonged survival by 50 percent in those faring poorly with kidney cancer. The sickest kidney-cancer patients were essentially kept alive for 10.9 months, compared with 7.3 months with interferon drugs. Torisel also postponed tumor growth for 5.5 months. This is 77 percent longer than with interferon.

Sutent and Nexavar, both on the market since last year, also slow tumor growth. All three kidney-cancer medicines are of the variety that block the growth of cancer cells -- different from standard chemotherapy which kills tumors and harms nearby tissues too.

Wyeth is relatively new to the oncology market. And soon, the company hopes to launch three more cancer drugs. One, called CMC-544, treats non-Hodgkin's lymphoma. Another, SKI-606, is for chronic myelogenous leukemia. And the third, HKI-272, is for breast cancer.

About 51,000 Americans will be diagnosed with kidney cancer this year.

Cancer drug Nexavar so good clinical trials end early

Cancer drug Nexavar has made its point. It can help people with liver cancer survive longer.

Bayer Pharmaceuticals and Onyx Pharmaceuticals announced Monday that advanced stage clinical trials for this drug will end early. And now patients in the placebo arm of the study can begin treatment with the actual drug.

It's been a long road for researchers who have been searching for a liver cancer treatment that can target tumors with minimal side effects while extending life for months or even years.

It is estimated that 16,780 people in the United States will die from liver cancer in 2007 -- and it seems Nexavar, a drug initially predicted to fail when used for liver cancer -- may help save some of these lives.

Bayer and Onyx are planning to pursue FDA approval for this drug that has already been approved for kidney cancer.

Liver cancer treated with Nexavar shows response in some patients

When cancer originates in the liver it is called hepatocellular carcinoma (HCC). In advanced HCC the cancer has spread to distant places in the body.

Biological pathways that are believed to be associated with cancer growth and spread can be targeted by Nexavar. A clinical trial was conducted consisting of 137 patients who have received no prior therapy and were unable to undergo the surgical removal of their cancer.

According to the article in the Journal of Clinical Oncology, Nexavar may provide anticancer activity in some patients with liver cancer and is well tolerated.

Also, a measure of 18 genes that were identified can help predict who will benefit from the drug Nexavar. Future clinical trials are being planned to evaluate the use of Nexavar in advanced hepatocellular carcinoma patients.

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