In Brief: Bristol’s Nivolumab Shows Survival, Boehringer Gains A Breakthrough & Sentinel Takes On Flu Vaccines, Plus CHMP Opinions
Bristol’s early stop of a nivolumab trial in melanoma offers the first late-stage, randomized survival data for the PD-1 class; Boehringer’s Pradaxa antidote is on the breakthrough track; CHMP clears Bristol’s daclatasvir ahead of FDA; and FDA concludes flu vaccines aren’t linked to seizures.
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Bristol’s combo demonstrates similar response rate as PD-1 alone, but with much better survival rates in a small melanoma study presented at ASCO. Due to toxicities, including one death, some say combination would need to shore up survival benefit to become first choice in frontline therapy.
Settlement expected to resolve approximately 4,000 Pradaxa personal injury claims.
FDA’s top cancer drug reviewer has taken to the podium to paint a picture of the next phase in cancer drug development, which includes new business models, a return to single-arm trials and a new emphasis on safety.