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Japan Keytruda NSCLC Approval Sets Stage For Opdivo Showdown

 
• By Ian Haydock

Keytruda has been approved in Japan for lung cancer, including first-line use, in a batch of new regulatory clearances that also include the country's first prescription drug for irritable bowel syndrome with constipation.

Approved

Merck Sharp & Dohme Ltd.'s (Merck & Co. Inc.) Keytruda (pembrolizumab) has received approval in Japan for the additional major indication of non-small cell lung cancer (NSCLC), and looks likely to reach the market in the first few months of next year after it receives a reimbursement price.

The PD-1-targeting antibody is indicated for PD-L1-positive unresectable advanced/recurrent NSCLC in both the first- and second-line treatment settings, and is administered at 200mg every three weeks. MSD KK will...

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More from Japan

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By Lisa Takagi

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

More from Asia

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.