Merck’s Keytruda: The ‘Wall Of Data’ Still Holds After ODAC Look Back
Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well. That will leave the product with 27 indications in the US – unless, of course, more are approved before the AA indications are formally pulled.
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FDA Panel Okays Keytruda’s Hepatocellular Carcinoma Indication, But Splits On Opdivo
In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.
Keytruda's Third-Line Gastric Cancer Indication Should Go, US FDA Panel Says
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.
Keytruda And FDA’s Oncology Center of Excellence: The Regulatory Milestones Keep Coming
Merck’s anti-PD-1 therapy Keytruda keeps piling up new indications, including three approved by US FDA in just two weeks – all during a pandemic. The remarkable therapy has been a centerpiece for an equally remarkable period of regulatory innovation.