Keytruda May Stay Competitive In Gastric Cancer Despite Losing Third-Line Claim
While Opdivo’s first-line approval has altered the treatment landscape, Keytruda may expand its presence there in the next few years with new indications.
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Citing changing therapeutic landscape and doubts about utility of checkpoint inhibitor monotherapy in this setting, advisory committee votes 6-2 against maintaining PD-1 inhibitor’s accelerated approval for third-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma.
Failed confirmatory trials for PD-1/L-1 inhibitor indications raise questions about marginal response rates in single-arm trials used to support accelerated approval, Oncology Center of Excellence leaders say in NEJM article that explains why the agency is taking six of these indications to its Oncologic Drugs Advisory Committee.
Execs told Scrip they hope to get Tyrvaya (varenicline) onto formularies and aim for pricing that would make its nasal spray competitive with Restasis and Xiidra.