Re: FDA Approves Votrient for Advanced Soft Tissue Sarcoma...

In continuation of my update on Pazopanib..


U.S. Food and Drug Administration, approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

Votrient is a pill that works by interfering with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.


A rare cancer with many subtypes, soft tissue sarcoma occurs in about 10,000 cases annually in the United States. More than 20 subtypes of sarcoma were included in the clinical trial leading to approval of Votrient. The drug is not approved for patients with adipocytic soft tissue sarcoma and gastrointestinal stromal tumors.

"Soft tissue sarcomas are a diverse group of tumors and the approval of Votrient for this general class of tumors is the first in decades," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Drug development for sarcomas has been especially challenging because of the limited number of patients and multiple subtypes of sarcomas."

The safety and effectiveness of Votrient was evaluated in a single clinical study in 369 patients with advanced soft tissue sarcoma who had received prior chemotherapy. Patients were randomly selected to receive Votrient or a placebo. The study was designed to measure the length of time a patient lived without the cancer progressing (progression-free survival). The disease did not progress for a median of 4.6 months for patients receiving Votrient, compared with 1.6 months for those receiving the placebo.

The most common side effects in Votrient-treated patients were fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor and muscle pain, hair color changes, headache, a distorted sense of taste, shortness of breath, and skin discoloration.

Votrient carries a boxed warning alerting patients and health care professionals to the potential risk of liver damage (hepatotoxicity), which can be fatal. Patients should be monitored for liver function and treatment should be discontinued if liver function declines.

Ref : http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10113.htm

Pazopanib for the treatment of advanced renal cell carcinoma.......

In continuation of my update on Pazopanib, I found this interesting info. In my earlier blog , I mentioned that lots of research groups are trying the same drug for other forms of cancer.  Dr. Cora Sternberg and co authors (Chief of the medical oncology department at the San Camillo and Forlanini Hospital in Rome, Italy), have come up with interesting results from a phase 3 study included 233 patients with previously untreated kidney cancer (also known as renal cell carcinoma) that was locally advanced or had spread, and 202 patients with renal cell carcinoma who had previously been treated with cytokine therapy (interferon or interleukin). The patients were randomly assigned to take pazopanib tablets (290 patients) or a placebo drug (145 patients).

As per the claim by the authors, in the pazopanib group, it took an average 9.2 months for the cancer to progress, vs. an average 4.2 months in the placebo group. The difference was greatest in previously untreated patients (11.1 months for the pazopanib group and 2.8 months for the placebo group), but also was found among patients previously treated with cytokines (7.4 months in the pazopanib group vs. 4.2 months in placebo group). 

Common side effects of pazopanib treatment included diarrhea (52 percent), high blood pressure (40 percent), hair color changes (38 percent), nausea (26 percent), weight loss (22 percent) and vomiting (21 percent).

Ref : http://jco.ascopubs.org/cgi/content/abstract/JCO.2009.23.9764v1 

Pazopanib for aggressive thyroid cancer.

There were lots of research groups involved in testing Pazopanib for diverse anticancer activity like "epithelial ovarian cancer, non small cell lung cancer and GSK was the key researcher and did try the phase III clinical trials in other cancer types, in Sept., 2008. Now thanx, Dr. Keith Bible, a medical oncologist and researcher who led the multicenter clinical trial funded by the National Cancer Institute, for this significant findings - cancer in about two-thirds of 37 patients with aggressive differentiated thyroid cancer treated with the drug pazopanib either stopped growing, or quickly shrank. And as per the conclusions : one-third of patients achieved sustained and dramatic benefit from pazopanib, while another one-third experienced stabilization of their cancer or some tumor shrinkage. The remaining one-third of patients did not benefit from the drug. The agent was also well tolerated by the majority of patients. Though further studies like - drug's effect on overall survival still to be established its a good beginning.

As per the authors conclusion majority of the patients with thyroid cancer respond well to surgery and to follow-up treatment with radioiodine; even if the cancer recurs and spreads, the disease progresses slowly in most patients. Many patients do well for a long time without the need of additional therapy. However, about 5 percent of these patients experience rapidly progressing life-threatening disease that is insensitive to radioiodine and other treatment approaches and for them this treatment will be a good one, the researchers claim. Congrats Dr. Bible and group..

Ref : http://www.mayoclinic.org/news2009-rst/5272.html