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news.Bristol-Myers Squibb has received the US Food and Drug Administration (FDA) approval for Yervoy (ipilimumab) 3mg/kg as the treatment for the patients who are suffering from unresectable (inoperable) or metastatic melanoma.
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In a pivotal randomized, double-blind Phase 3 study, the drug has shown improvement in overall survival based on results.
In the trial, the median overall survival was 10 months (95% CI: 8.0-13.8) for Yervoy, 6 months for gp100 and 10 months for Yervoy + gp100, with p-values of 0.0026 (not adjusted for multiple comparisons) for Yervoy and 0.0004 for YERVOY + gp100 vs. gp100, respectively.
Bristol-Myers Squibb CEO Lamberto Andreotti said this approval of YERVOY is an example of the company living its mission of developing and delivering innovative medicines that address the unmet needs of patients with serious diseases.
Bristol-Myers Squibb Research & Development chief scientific officer president and executive vice president said Yervoy is the first FDA-approved compound from their immuno-oncology pipeline, which comprises a variety of other compounds with the potential to harness the patient’s immune system to fight cancer.