Therapy Areas: Cardiovascular
FDA Grants Bristol-Myers Squibb Approval for Opdivo (nivolumab) as Adjuvant Therapy in Certain Patients with Completely Resected Melanoma
22 December 2017 - - New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) has received US Food and Drug Administration approval for Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, the company said.
The purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumor and lymph nodes that contain cancer.
In the CheckMate -238 trial, an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma, Opdivo significantly improved recurrence-free survival versus an active comparator, Yervoy (ipilimumab), in patients with stage IIIB/C or stage IV melanoma after surgery.
This benefit was observed across important subgroups, including in both BRAF mutant and BRAF wild-type patients.
Opdivo, a PD-1 immune checkpoint inhibitor designed to overcome immune suppression, is the first and only agent approved for the adjuvant treatment of melanoma based on a head-to-head trial against an active comparator with a proven overall survival benefit.
Opdivo's leading global development program includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide.
The company offers chemically-synthesised drug and biologic in various therapeutic areas, such as oncology; cardiovascular; immunoscience; and virology comprising human immunodeficiency virus infection (HIV).
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