FDA Clears Yervoy for Treatment of Melanoma to Extend Life of Patients

Some of the side effects include diarrhea, swelling of the colon, rash and fatigue. The drug is from Bristol Myers and the study done contained 676 patients who all had advanced melanoma. The average life extension was around 3 months but the study had some that lived far longer. There was no mention yet on what the drug will cost.

Bristol in 2012 will lose their patent on Plavix so a new approval can’t hurt when it comes time to replace lost sales revenue. BD

(AP) -- The Food and Drug Administration has approved a breakthrough cancer medication from Bristol-Myers Squibb Co. that researchers have heralded as the first drug to prolong the lives of patients with melanoma.

The federal health agency approved the injectable drug, called Yervoy, for late-stage or metastatic melanoma. The agency has only approved two other drugs for advanced melanoma, the last of which was cleared more than 13 years ago. Neither drug has been shown to significantly extend patient lives.

Known chemically as ipilimumab, the biotech drug only worked in a small segment of patients studied, and on average they lived just four months longer than patients given older medications. But experts say the drug is an important milestone in treating the deadliest form of skin cancer, which is often unresponsive to therapy.

FDA clears first melanoma drug to extend survival