Posted by Michael Wonder on 21 Dec 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease
20 December 2017 - Opdivo, the first and only anti-PD-1 immune checkpoint inhibitor approved for adjuvant treatment of melanoma, is indicated for both BRAF mutant and wild type patients.
Bristol-Myers Squibb Company announced today that the U.S. FDA has approved 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 purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumour and lymph nodes that contain cancer. In the Phase 3 CheckMate-238 trial, 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.
