Merck & Co., the leading American biopharmaceutical company, has reportedly announced that Keytruda, which is its proprietary PD-L1 therapy, has received conditional approval in China to be used in the treatment of first-line metastatic NSCLC (non-squamous non-small cell lung cancer), together with several chemotherapies.
As per trusted sources, the drug, in combination with the Eli Lilly’s LLY Alimta (pemetrexed) & platinum chemotherapy, received approval for treating adult lung cancer patients with tumors having no ALK or EGFR positive mutations. Sources added that a further confirmatory study on Chinese patients is essential in the aforesaid indication for continued approval. For a similar indication, the drug has already been approved in Europe and the United States. Keytruda, for the record, is approved in China for advanced melanoma.
If reports are to be believed, the latest approval arose on the basis of data from a significant KEYNOTE-189 study which highlighted the influence of Keytruda combination regimen in the improvement of OS (overall survival) and PFS (progression free survival) over chemotherapy. The Keytruda combination significantly reduced death risks by about 51 percent, in comparison to chemotherapy alone. In the meantime, the PFS was also found to have drastically improved.
Keytruda has successfully become the largest revenue generator for Merck, with its sale of over $7 billion in the year 2018. Over the years, the company has expanded the Keytruda label, with one of the pivotal ones being for first-line lung cancer indication. Many other pharma companies are also striving to get their drugs sanctioned in the first-line NSCLC. For the record, AZN Tagrisso by AstraZeneca gained approval in June 2018, for the first-line NSCLC across Europe.
Apparently, the approval is anticipated to bolster the drug’s prospects, owing to a considerable patient population within the country. Indeed, it has been speculated that over 626,000 patients pass away every year in China, due to cancer.