Merck’s Keytruda Receives NMPA’s Approval as Monotherapy for 1L Treatment of Advanced Non-Small Cell Lung Cancer with PD-L1 Tumor Expression in China

 Merck’s Keytruda Receives NMPA’s Approval as Monotherapy for 1L Treatment of Advanced Non-Small Cell Lung Cancer with PD-L1 Tumor Expression in China

Merck’s Keytruda Receives NMPA’s Approval as Monotherapy for 1L Treatment of Advanced Non-Small Cell Lung Cancer with PD-L1 Tumor Expression in China

Shots:

  • The NMPA approval is based on the P-III KEYNOTE-042 study assessing Keytruda as monothx. vs CT in patients with stage III NSCLC who were not candidates for surgical resection/definitive chemoradiation/mNSCLC with PD-L1 expression & no prior systemic treatment for mNSCLC including data from the extension of KEYNOTE-042 in Chinese patients
  • The extension study results demonstrated improvement in OS in patients whose tumors expressed PD-L1 with a TPS ≥50%, TPS ≥20% and in the entire study population with a TPS ≥1%
  • KEYTRUDA is an anti-PD-1 therapy, act blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 thus activating T lymphocytes affecting both tumor and healthy cells and is the first anti-PD-1 therapy to be approved as both monothx. & in combination with CT as 1L treatment for NSCLC in China

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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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