Bristol-Myers
Squibb Company BMY announced Saturday, that the U.S. Food and
Drug Administration (FDA) has approved Opdivo (nivolumab) in
combination with Yervoy (ipilimumab) for the treatment of
patients with BRAF V600 wild-type and BRAF V600
mutation-positive unresectable or metastatic melanoma.1 This
indication is approved under accelerated approval based on
progression-free survival (PFS).1 Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.1 This approval
expands the original indication for the Opdivo + Yervoy Regimen
for the treatment of patients with BRAF V600 wild-type
unresectable or metastatic melanoma to include patients, regardless of BRAF
mutational status, based on data from the Phase 3 CheckMate -067
See full press release
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