Navigation Links
YERVOY (ipilimumab) approved for the treatment of previously treated advanced melanoma in the EU

Paris, 14 July 2011 Bristol-Myers Squibb today announced that the European Commission has approved YERVOY (ipilimumab) for the treatment of adult patients with previously-treated advanced melanoma.

YERVOY, an innovative immunotherapy, showed long-term survival in the treatment of patients with advanced melanoma in a randomised, double-blind Phase III study published in the New England Journal of Medicine in June 2010.(1) Based on the survival (Kaplan-Meier) curve, the 1 and 2-year estimated survival rates for patients treated with YERVOY were 46% and 24% respectively vs. 25% and 14% in the comparator arm with some patients alive at 3 and 4 years.

"With the approval of YERVOY physicians now have an important new option to offer to patients with metastatic melanoma. 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," comments Professor Alexander Eggermont, General Director, Institut Gustave Roussy, Paris, France. "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 4 infusions over 3 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."

Bristol-Myers Squibb will now work closely with local health authorities to expedite the availability of YERVOY across the European Union. Prior to approval, the Company provided ipilimumab to nearly 3,000 patients throughout Europe through Compassionate Use / Named Patient Programmes. The Company remains committed to helping ensure that appropriate patients who need YERVOY will receive it while the reimbursement process is finalised by the relevant authorities throughout Europe.

Ron Cooper, President Bristol-Myers Squibb Europe, stated: "With an average survival time on diagnosis of 6-9 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. 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 represents a new treatment paradigm in the evolving discipline of immuno-oncology. It indirectly targets the tumour by stimulating the patient's immune system to recognise and destroy cancer cells.(2) YERVOY specifically blocks cytotoxic T lymphocyte antigen 4 (CTL4), which plays a role in suppressing the normal immune response. YERVOY blocks that suppression to allow the immune system to respond to melanoma cancer cells.

The types of adverse events (AEs) attributed to YERVOY are generally mechanism (immune)-based. YERVOY can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Patients should be assessed for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and clinical chemistries should be evaluated, including liver function tests and thyroid function tests, at baseline and before each dose.

Adverse events associated with YERVOY are managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.


Contact: Elzbieta Zawislak

Related medicine news :

1. Rochester technology to enhance eyesight approved by FDA
2. FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds
3. New drug for use in bone scans approved
4. Pradaxa Approved to Fight Dangerous Irregular Heartbeat, Stroke
5. First Patient Treated in U.S.-Approved Embryonic Stem Cell Trial
6. The Good Nite Lite Awarded the Parent Tested Parent Approved Seal
7. U.S. FDA Adds 25 New Firms to Import Alert for Promotion of Unapproved New Drugs According to, LLC
8. doeLegal and Zapproved Sign Alliance to Add Legal Hold Pro to Suite of Powerful Online Legal Solutions
9. Parent Tested Parent Approved Media Announces their Winning Products for the Summer 2010 Campaign
10. Expert Approved: FatWallet Guides Mother's Day Shoppers to the Best Deals Online
11. Khanna Institute to Offer Newly FDA Approved Expanded Range of Intacs for Keratoconus
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term ... long-term care insurance companies have a waiver for care if the client has a ... when the family pays for care, is often waived, so the benefits from their ...
(Date:10/13/2017)... ... 13, 2017 , ... Talented host, actor Rob Lowe, is ... a new episode of "Success Files," which is an award-winning educational program broadcasted ... each subject in-depth with passion and integrity. , Sciatica occurs when the sciatic ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco dentists, ... cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated to ... breathing. Oral appliances can offer significant relief to about 75 percent of people ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... ... ... On Saturday, October 21, the Health & Wellness Center at Florida Hospital ... for the American Heart Association Heart Walk. Teams of up to 10 people can ... their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on Saturday, ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global ... that its MyDario product is expected to appear on The Dr. Oz ... Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, The Dr. Oz Show kicked ... The segment features ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has ... the Atlanta Football Host Committee (AFHC) for the 2018 College ... Jan. 8, 2018, at Mercedes-Benz Stadium in Atlanta, ... of the AFHC "I,m In" campaign, participating in many activities ... ...
Breaking Medicine Technology: