A drug that looked like it could do no wrong in the FDA's eyes, Bristol-Myers Squibb Co.'s Opdivo (nivolumab), actually got a rejection from the agency to expand the medicine's use as a single agent for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Opdivo Gets A Melanoma Rejection, But Also An Expansion
A drug that looked like it could do no wrong in the FDA's eyes, Bristol-Myers Squibb Co.'s Opdivo (nivolumab), actually got a rejection from the agency to expand the medicine's use as a single agent for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
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