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Merck bags Chinese OK for Keytruda in first-line lung cancer

Country has 782,000 new lung cancer cases each year

merck

Merck & Co/MSD has made another stride forward with its cancer immunotherapy Keytruda, which has become the first PD-1 inhibitor to approved for multiple tumour types in China.

The new approval is a big one too, making Keytruda (pembrolizumab) a first-line treatment option alongside chemotherapy for patients in China with metastatic non-squamous non-small cell lung cancer (NSCLC) – an indication that has been driving Keytruda’s breakneck sales growth in the last few years to more than $7bn in 2018.

Lung cancer is a big problem in China, with the highest incidence and mortality among all cancers in the country. More than 782,000 new cases of the disease each year, claiming the lives of more than 626,000 people, according to Merck. NSCLC s the most common form of lung cancer – accounting for 85% of all cases – and the non-squamous type is also the most common form of NSCLC.

Keytruda was first approved in China last July for advanced melanoma, and is the first anti-PD-1 therapy approved by the country’s National Medical Products Administration (NMPA) as a first-line treatment for metastatic non-squamous NSCLC.

The NMPA has granted the drug a conditional approval, which means it is accepting the results of the KEYNOTE-189 which underpinned Keytruda’s approval for this indication in the US, Europe and Japan. A permanent approval will depend on positive results in Chinese patients in a confirmatory trial.

Roy Baynes

Roy Baynes

“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.

Bristol-Myers Squibb’s rival PD-1 inhibitor Opdivo (nivolumab) was the first checkpoint inhibitor to be approved in China, getting the go-ahead as a second-line treatment for advanced NCLC in June 2018.

The first domestically-developed checkpoint inhibitor to be approved in China was Shanghai Junshi Biosciences Tuoyi (toripalimab), which got a green light from the NMPA in December 2018.

Since then it has been joined by Tyvyt (sintilimab), jointly developed by Chinese biotech Innovent and Eli Lilly, which has been cleared for relapsed or refractory classical Hodgkin's lymphoma (cHL). Beigene’s tislelizumab is meanwhile heading for a regulatory verdict in China for the same indication as Tyvyt.

China is the world's second-largest market for pharmaceuticals, worth $122.6bn in 2017 according to IQVIA, and the fastest emerging market for the sector with its size expected to swell to $145bn-$175bn by 2022.

Article by
Phil Taylor

2nd April 2019

From: Regulatory

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