PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.
Ipilimumab is Bristol-Myers Squibb's second drug under priority review by the FDA this year. A priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on FDA’s six month goal for completing priority reviews, the projected FDA action date is December 25, 2010.
The filing is based on results from the primary analysis of the pivotal MDX010-020 trial, which were published online in the New England Journal of Medicine and presented during a plenary session at the 46th Annual Meeting of the American Society of Clinical Oncology in June 2010. The study compared the overall survival rate of patients who received ipilimumab plus the gp100 vaccine (3 mg/kg and 1mg/kg every three weeks for four doses; n=403), ipilimumab alone (3 mg/kg every three weeks for four doses; n=137) and the control therapy of gp100 alone (n=136).
Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities for the treatment of adult patients with previously treated advanced melanoma.
Ipilimumab is a novel T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. Suppression of CTLA-4 can augment the immune system’s T-cell response. Ipilimumab is an investigational compound and is not currently approved for use by health authorities.
About Metastatic Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. As with many cancers, it is more difficult to treat once the disease has spread beyond the skin to other parts of the body by way of the bloodstream or the lymphatic system (metastatic disease).
The incidence of melanoma has increased ten-fold over the past 50 years, and has steadily increased since the 1970s. The American Cancer Society (ACS) estimates that there were approximately 68,000 new cases of melanoma in the U.S. in 2009. Melanoma accounts for about three percent of skin cancer cases, but it causes most skin cancer deaths. The ACS estimates that, in 2009, there were approximately 8,700 deaths from melanoma in the U.S.
About Bristol-Myers Squibb
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that ipilimumab will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise
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