PARIS—Bristol-Myers Squibb has announced that YERVOY(ipilimumab), its immunotherapy treatment for patients with metastaticmelanoma, has received approval from the European Commission as a treatment foradult patients with previously treated advanced melanoma.
The approval was based on the results of a randomized,double-blind Phase III study that showed that based on the survival(Kaplan-Meier) curve, the one- and two-year estimated survival rates for thepatients who received YERVOY were 46 percent and 24 percent respectively,compared to 25 percent and 14 percent in the other arm of the study. The EUapproval comes approximately four months after YERVOY received U.S. Food andDrug Administration (FDA) approval on March 25. The FDA approved YERVOY 3 mg/kgfor the treatment of unresectable or metastatic melanoma.
"With an average survival time on diagnosis of six to ninemonths, patients with advanced melanoma have had little hope -- until now. TheEuropean Union approval of YERVOY is a milestone for patients with advanceddisease and is the first outcome of Bristol-Myers Squibb's commitment toimmuno-oncology," Ron Cooper, president of Bristol-Myers Squibb Europe, said ina press release. "Through the Bristol-Myers Squibb String of Pearls strategy,we began a collaboration with Medarex, acquired the company and developedYERVOY. We will continue this strategy to seek and establish collaborationswith other leading innovators across the globe. Through these and otherinitiatives we work towards our single mission: to discover, develop anddeliver innovative medicines that help patients prevail over serious diseases."
YERVOY works to target tumors by stimulating a patient's ownimmune system so that it can recognize and destroy cancers, representing a newimmuno-oncology treatment paradigm. By blocking cytotoxic T lymphocyte antigen4 (CTL4), which is known to suppress a body's normal immune response, YERVOYalso blocks the immune-suppression effect, allowing the body's immune system totarget and respond to melanoma cancer cells. The adverse reactions associatedwith YERVOY are largely immune-based due to T-cell activation andproliferation, with the most common adverse reactions being hepatitis,dermatitis, enterocolitis, endcrinopathy and neuropathy.
Melanoma, while the least common of all skin cancers, isalso the most deadly. Advanced melanoma takes place when the cancer spreads toother organs, and while it is treatable, 75 percent of patients with metastaticmelanoma die within one year. Given the lack of options and the speed withwhich the cancer can spread, since it can often avoid detection by the immunesystem, there is a strong need for better treatment options. YERVOY, accordingto Prof. Alexander Eggermont, General Director of the Institut Gustave Roussyin Paris, is one such option. "This is a chance of not just months but potentially 3 to 4years of prolonged survival for some patients in the treatment of metastaticmelanoma," said Eggermont in a press release about YERVOY '
s approval. "There is hope that YERVOY's novel mode of action,together with the fact that the recommended complete course of treatment withYERVOY (3 mg/kg) includes four infusions over three months, could potentiallychange the way we treat patients with previously treated advanced melanoma. Itis an example of what can be done through unleashing the power of one's ownimmune response."
Before it gained approval, Bristol-Myers Squibb providedYERVOY to approximately 3,000 patients in Europe through Compassionate Use/NamedPatient Programmes. Moving forward, Bristol-Myers Squibb will work with localhealth authorities to speed up YERVOY's availability in the EU.
