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How Is Merck’s Keytruda Positioned in September?

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Keytruda revenue trends

Merck’s (MRK) Keytruda has witnessed ~89% YoY (year-over-year) growth and generated second-quarter revenues of $1.7 billion. In the US market, Keytruda’s second-quarter revenues grew 73.0% to reach $959.0.0 million. In the international markets, Keytruda’s revenues increased ~118.0% YoY to reach $707.0.0 million. In the first half of the year, Keytruda generated revenues of $3.1 billion for ~114.0% YoY growth.

Among Keytruda’s peers, Roche’s (RHHBY) Avastin, Bristol-Myers Squibb’s (BMY) Opdivo, and Novartis’ (NVS) Afinitor reported revenues of 3.4 billion Swiss francs, $2.3 billion, and $783.0 million, respectively, in the first half of 2018.

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Recent approval

In September, the European Commission approved Keytruda in combination with Alimta and platinum-based chemotherapy in the first-line setting. This combination is intended for the treatment of individuals with metastatic nonsquamous non-small cell lung cancer (or NSCLC) whose tumors do not have EGFR or ALK-positive mutations. In August, the FDA approved a Keytruda, Alimta, and platinum-based chemotherapy combination for the treatment of the same indication.

The European Commission’s approval for the label expansion of Keytruda was based on the data from the Phase 3 KEYNOTE-189 trial. The approval for the label expansion of Keytruda is expected to allow Merck to commercialize the drug for the approved indication in all 28 European Union countries. The approval of label expansion of Keytruda could significantly boost the drug’s revenue growth in 2018 and beyond.

Lung cancer is one of the leading causes of cancer-associated deaths in Europe and around the world. According to Eurostat, more than 272,000 individuals died due to lung cancer in 28 European Union countries in 2014. NSCLC and small cell lung cancer are two major types of lung cancer. NSCLC is most common lung cancer, accounting for 85.0% of all lung cancer.

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