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Merck: KEYTRUDA Approved For New Indication In China - Quick Facts

Merck (MRK) said KEYTRUDA, the company's anti-PD-1 therapy, has been approved by the National Medical Products Administration in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 as determined by a fully validated test, following failure of one prior line of systemic therapy. The company noted that, with the new approval, KEYTRUDA is now approved for five indications across three different types of cancer in China.

Separately, Merck reported results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company's investigational 15-valent pneumococcal conjugate vaccine. The company said V114 met safety and immunogenicity objectives in initial phase 3 studies in adults. The company plans to continue to work with the FDA and other regulatory authorities around the world on filing plans for licensure of this vaccine as more data from the Phase 3 program become available.

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