FDA approves PD-1 monoanti-Keytruda's second biomarker-based tumor indication
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Last Update: 2020-06-25
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Source: Internet
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Author: User
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Merck announced thatFDAapproved its PD-1 monoantitic Keytruda (pembrolizumab) for the treatment of patients with high tumor mutation load (TMB-H) who cannot remove or metastatic solid tumors, who have progressed after previous treatment and have no other alternative optionsThe approval marks the second time that anti-PD-1 therapy has been approved for the treatment of biomarker-based indications, previously approved for use in certain patients with instability, high or mismatched defects that cannot be removed or metastaticMerck says the latest accelerated approvalist is based on the persistence of tumor response rates and response data based on the KEYNOTE-158 studyThe results showed that in 102 cases of TMB-H tumor patients, Keytruda had an objective remission rate of 29%, a full remission rate of 4% and a partial remission rate of 25%
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