1. Pink Sheet
  2. >>Geography
  3. >>Asia
  4. >>Japan

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Japan

Leqembi Facing 15% Price Cut In Japan

 
• By Lisa Takagi

Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

More from Asia

Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges