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Bristol-Myers Squibb's Opdivo + Yervoy Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status1

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Bristol-Myers
Squibb Company (NYSE: 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

Posted-In: News FDA Press Releases

 

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