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

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

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: Merck | Image: Biospace

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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