As we wrote about back in June, the most promising drug in the war on Melanoma, ipilimumab, was fast-tracked and finally approved as “Yervoy” for Bristol-Myers Squibb by the FDA last week.

Ipi is an immune therapy drug: it tries to activate or stimulate the immune system to clear cancer cells. While ipi’s funny name has not improved much with a brand name like Yervoy, it is anything but laughable.  We have been challenged to make ANY progress with drug therapy and this new therapy is a welcome advance. With the usual current immuno-therapy treatments, such as interleukin, we haven’t been able to significantly extend the immune response to melanoma cells.  As described on WebMD:

Yervoy appears to extend survival when used as a first-line treatment for inoperable stage III or stage IV melanoma, Bristol-Myers announced earlier this week. Details of the study will be reported at the June meeting of the American Society of Clinical Oncology.

Yervoy is a biologic therapy. It’s a kind of man-made antibody (a monoclonal antibody) that blocks a crucial switch on immune cells called CTLA-4. Cancers use this switch to turn off the body’s anticancer immune responses.

Most drugs like this come with possibly severe side effects, and Yervoy is no exception. The drug can provoke powerful autoimmune reactions in which the immune system attacks normal cells in the body. In clinical trials, nearly 13% of patients taking Yervoy had severe or fatal autoimmune reactions.

Even with those caveats this does seem to be some light at the end of the tunnel:

FDA approved the drug based on a Bristol Myers study of 676 people with advanced, inoperable melanoma who had already failed two other treatments, giving them a very short life expectancy. They were given one of three treatments: ipilimumab by itself, ipilimumab combined with another immune-stimulating treatment, or the immune-stimulating treatment alone.

Average survival was 10 months with ipilimumab versus just more than six months for the others. But a very small group of patients survived longer than six years, suggesting that with more study the drug could be targeted to those who will respond the most.

About 85 percent of patients had little response to the drug. Researchers say the response rate should improve as the drug is used earlier in the disease cycle.

“I think the direction this is headed is toward intervening earlier, when patients’ immune systems are still intact, rather than waiting until they are so sick,” said Dr. Anna Pavlick, director of the New York University’s melanoma program. Pavlick, a spokeswoman for the Skin Cancer Foundation, helped conduct several early-stage trials of ipilimumab.

Bristol-Myers Squibb expects to begin shipping YERVOY within weeks.