Due to its effects in terms of T-cell activation andproliferation, YERVOY can cause immune-mediated adverse reactions that rangefrom severe to fatal, with the most common severe immune-mediated adversereactions being hepatitis, dermatitis (including toxic epidermal necrolysis),enterocolitis, neuropathy and endocrinopathy. The most common adverse reactionsto YERVOY were fatigue, diarrhea, pruritus, rash and colitis.
As for Roche's drug,vemurafenib is created to inhibit a mutated form of the BRAF protein that isfound in almost half of all cases of melanoma.
"We have worked swiftly toadvance the vemurafenib development program, knowing that patients withmetastatic melanoma have a poor prognosis and limited treatment options," saidHal Barron M.D., Chief Medical Officer and Head of Global Product Developmentat Roche in a statement regarding the compound's New Drug Application. "Theregulatory submissions of vemurafenib and the companion diagnostic to identifypeople with the type of melanoma specifically targeted by this medicine areexciting steps toward our goal of delivering a personalized therapy for thisdisease."
Metastatic melanoma is thedeadliest form of skin cancer, and the
National Cancer Institutes (NCI) predicted 68,130 new cases in the United Statesin 2010, and 8,700 deaths. It is aggressive, and prognosis is particularly poorif the cancer has spread. The NCI reports that if the melanoma is localized,the relative five-year survival rate is 98.1 percent. Once it has metastasized,the five-year survival rate plummets to 15.3 percent.
No financial details regarding the collaboration werereleased.