Ipilimumab Approval Highlights Active Immunotherapy Renaissance

25 March 2011

Life Science Digest

On Friday, March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy® [ipilimumab] by Bristol-Myers Squibb for the treatment of patients with late-stage melanoma.

Approval of ipilimumab is the second victory for the field of active immunotherapy in oncology within a year.   On April 29, 2010, the FDA approved the very first active immunotherapy for the treatment of cancer - Dendreon Corporation's Provenge® for metastatic castrate-resistant prostate cancer.  The fact that two active immunotherapies have demonstrated improved survival in randomized Phase 3 trials and subsequently been approved by the FDA has reignited enthusiasm for the field of active immunotherapy, which has experienced nearly a dozen failures in Phase 3 clinical trials.

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