China approves Keytruda for non-small cell lung cancer

pharmafile | April 2, 2019 | News story | Manufacturing and Production China, MSD, Merck and Co, USA, keytruda, lung cancer, pharma 

US firm MSD has won approval for Keytruda in China. The cancer immunotherapy has thus become the first PD-1 inhibitor approved for multiple tumour types in China.

The approval makes Keytruda (pembrolizumab) a first line treatment option alongside chemotherapy for patients in China with metastatic non-squamous non-small cell lung cancer (NSCLC). The indication brought in more than $7 billion in sales in 2018.

Amid major problems with air pollution, lung cancer is on the rise in China, which has the highest incidence and mortality rates for the disease amongst all countries in the world.

There are 782,000 new cases of lung cases in China each year – in around 626,000 of those cases, the patient dies.

While Keytruda was first approved in China for advanced melanoma in July of last year, the National Medical Products Administration (NMPA) has been granted a conditional approval dependent on positive results in a future confirmatory trial.

“This approval represents a key advance in a country with a high incidence of lung cancer, and where significant progress for the first-line treatment of this devastating disease has been very limited over a number of years,” commented Roy Baynes, Merck’s chief medical officer.

Louis Goss

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