Merck's Keytruda (pembrolizumab) Receives Two New PMDA's Approvals in Japan

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Merck's Keytruda (pembrolizumab) Receives Two New PMDA's Approvals in Japan


  • The first approval is for certain ESCC patients- which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.)
  • Additionally- Keytruda received approval for use at an additional recommended dosage of 400mg- q6w- IV over 30 minutes across all adult indications- including both monothx. and combination therapy
  • The approval for q6w dosing regimen is based on PK modeling and exposure-response analyses & was supported by an interim analysis of KEYNOTE-555 from a cohort of patients (Cohort B) treated with Keytruda (400mg- q6w). With the approvals- Keytruda has 13 indications across seven tumor types plus MSI-H tumors in Japan

­ Ref: Merck | Image: Merck 

Click here to­ read the full press release 

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