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Bristol-Myers Squibb announced that the FDA has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy (ipilimumab) for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection.
The sBLA submission was based on clinical results from CA184-029, a Phase 3 randomized, double-blind trial, assessing the efficacy of Yervoy in preventing or delaying recurrence after complete resection of high-risk stage 3 melanoma.
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Yervoy is already approved as monotherapy for the treatment of unresectable or metastatic melanoma. It is currently being studied in Phase 3 trials for patients with mCRPC who have not received prior cytotoxic treatment (Study 095) and in adjuvant melanoma and non-small cell lung cancer.
For more information call (800) 321-1335 or visit BMS.com.
