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German drug maker Bayer AG and Onyx Pharmaceuticals on Monday announced they ended a Phase III trial of drug Nexavar because it was determined that the study wouldn’t meet its primary endpoint of improved overall survival among melanoma patients receiving the drug in combination with chemotherapy.
“We’re disappointed with the results of the study and that the therapy did not bring benefit to patients with melanoma, a historically difficult tumor to treat,” Dr. Todd Yancey, vice president of clinical development at Onyx, said.
The trial was sponsored by the National cancer Institute and was aimed to improve overall survival in patients receiving Nexavar in combination with chemotherapy, against those receiving a placebo with chemotherapy.
Nexavar is currently approved in more than 70 countries for patients with lover cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer.
Global Nexavar sales grew 82% year over year to $677.8 million in 2008. In February, Onyx said sales of Nexavar would be in the range of $850 million to $875 million in 2009 and more than $1 billion in 2010.
The American Academy of Dermatology estimates that nearly 63,000 people are diagnosed with melanoma in the U.S. every year, and about 8,400 die from the disease. The main risk factor for developing melanoma is ultraviolet radiation.
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