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Merck's Keytruda approved in China

Apr 04, 2019
By Pharmaceutical Executive Editors
Merck, known as MSD outside the United States and Canada, has announced that Keytruda, its anti-PD-1 therapy, has been approved by China's National Medical Products Administration (NMPA) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
 
Lung cancer is the leading cause of cancer death in China and worldwide. Each year, more than 782,000 new cases of lung cancer are diagnosed in China and more than 626,000 deaths result from the disease. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85 percent of all cases. 
 
This new indication was granted conditional approval based on overall survival (OS) and progression-free survival (PFS) data from the pivotal Phase 3 KEYNOTE-189 trial in patients regardless of PD-L1 tumor expression status. 
 
Joseph Romanelli, president of Merck in China, commented: “Patients with metastatic nonsquamous non-small cell lung cancer in China now have a new option for the first-line treatment of their disease, and we will continue to collaborate with the Chinese government, healthcare organizations and our business partners to improve patient access to Keytruda in 2019.”
 
 
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