Bristol-Myers Squibb’s YERVOY nets EU approval
PARIS—Bristol-Myers Squibb has announced that YERVOY (ipilimumab), its immunotherapy treatment for patients with metastatic melanoma, has received approval from the European Commission as a treatment for adult 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 the patients 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 EU approval comes approximately four months after YERVOY received U.S. Food and Drug Administration (FDA) approval on March 25. The FDA approved YERVOY 3 mg/kg for the treatment of unresectable or metastatic melanoma.
"With an average survival time on diagnosis of six to nine months, patients with advanced melanoma have had little hope -- until now. The European Union approval of YERVOY is a milestone for patients with advanced disease and is the first outcome of Bristol-Myers Squibb's commitment to immuno- oncology," Ron Cooper, president of Bristol-Myers Squibb Europe, said in a press release. "Through the Bristol-Myers Squibb String of Pearls strategy, we began a collaboration with Medarex, acquired the company and developed YERVOY. We will continue this strategy to seek and establish collaborations with other leading innovators across the globe. Through these and other initiatives we work towards our single mission: to discover, develop and deliver innovative medicines that help patients prevail over serious diseases."
YERVOY works to target tumors by stimulating a patient's own immune system so that it can recognize and destroy cancers, representing a new immuno-oncology treatment paradigm. By blocking cytotoxic T lymphocyte antigen 4 (CTL4), which is known to suppress a body 's normal immune response, YERVOY also blocks the immune-suppression effect, allowing the body's immune system to target and respond to melanoma cancer cells. The adverse reactions associated with YERVOY are largely immune-based due to T-cell activation and proliferation, with the most common adverse reactions being hepatitis, dermatitis, enterocolitis, endcrinopathy and neuropathy.
Melanoma, while the least common of all skin cancers, is also the most deadly. Advanced melanoma takes place when the cancer spreads to other organs, and while it is treatable, 75 percent of patients with metastatic melanoma die within one year. Given the lack of options and the speed with which the cancer can spread, since it can often avoid detection by the immune system, there is a strong need for better treatment options. YERVOY, according to Prof. Alexander Eggermont, General Director of the Institut Gustave Roussy in Paris, is one such option.
"This is a chance of not just months but potentially 3 to 4 years of prolonged survival for some patients in the treatment of metastatic melanoma, " 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 with YERVOY (3 mg/kg) includes four infusions over three months, could potentially change the way we treat patients with previously treated advanced melanoma. It is an example of what can be done through unleashing the power of one's own immune response."
Before it gained approval, Bristol-Myers Squibb provided YERVOY to approximately 3,000 patients in Europe through Compassionate Use/Named Patient Programmes. Moving forward, Bristol-Myers Squibb will work with local health authorities to speed up YERVOY's availability in the EU.