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Merck's Keytruda Wins FDA Nod for First-Line Head/Neck Cancer

With the latest approval, Keytruda can be prescribed to previously untreated patients with metastatic or with unresectable, recurrent HNSCC as monotherapy in patients whose tumors express PD-L1 [CPS (combined proportion score )≥1) or in combination with chemotherapy regardless of PD-L1 expression. The sBLA was based on data from the phase III KEYNOTE-048 study, wherein Keytruda, as a monotherapy and in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, demonstrated significant improvement in overall survival compared to the standard of care in the given patient population. Keytruda generated sales of $2.27 billion in the first quarter of 2019, up around 5.6% sequentially and 55% year over year. In fact, the Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1000 studies, including more than 600 combination studies.

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