Bristol-Myers (BMY) Melanoma Drug Approved

Bristol-Myers Squibb (NYSE:BMY) had it drug Yervoy approved by the Food and Drug Administration on Friday, the first drug that has been effective in prolonging the lives of people with the skin cancer melanoma

“This is really the first time in the melanoma field that there is a drug that extended survival in a meaningful way,” said Dr. Gerald P. Linette, an assistant professor of medicine at Washington University in St. Louis, cited by the New York Times.

The Times added, "In a randomized clinical trial, patients with metastatic melanoma treated with Yervoy lived a median of about 10 months, compared with 6.4 months for patients in a control group, who received a treatment believed to have had little effect.

"After two years, more than 20 percent of those who got Yervoy, also known as ipilimumab, were alive, compared with 13.7 percent for the control group.

"Bristol-Myers said it would charge $120,000 for a complete course of treatment, which consists of four infusions given over a three-month period.

"There were about 68,000 new cases of melanoma in the United States last year and 8,700 deaths, according to the American Cancer Society. The number of cases has been rising, probably because of sun exposure without proper protection at a younger age."

Bristol-Myers was trading at $27.42, gaining $0.99, or 3.75 percent, as of 2:40 PM EDT.




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Onyx Pharmaceuticals' (Nasdaq:ONXX) Carfilzomib Fast-Tracked by FDA

The U.S. Food and Drug Administration (FDA) granted Onyx Pharmaceuticals' (Nasdaq:ONXX) Carfilzomib fast-track designation

Carfilzomib is the multiple-myeloma drug of Onyx Pharmaceuticals.

What this means is the review process will accelerate, and Onyx will be allowed to to submit its carfilzomib application on a rolling basis. With the fast-track, the company believes they could end the process by the middle of 2011. They already have the process in motion.

Onyx closed Monday at $35.28, gaining $0.78, or 2.25 percent.