Merck’s Keytruda receives four approvals in Japan, including in high-risk early-stage TNBC

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Merck, known as MSD outside of the United States and Canada, today announced that Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare. The indications included TNBC, renal cell carcinoma, cervical cancer, and melanoma. 

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FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.
The European Commission approved Keytruda (pembrolizumab), an anti-PD-1 therapy, as a monotherapy for the treatment of resectable locally advanced head-and-neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score ≥1. 

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