US FDA accepts two applications seeking approval of pembrolizumab for the treatment of patients with triple-negative breast cancer (TNBC)

The applications seek approval for 1) treatment in combination with chemotherapy (CT) for locally recurrent unresectable or metastatic TNBC where the tumours express PD-L1, and 2) neoadjuvant (with CT) and adjuvant (single-agent) treatment of high-risk early stage TNBC.

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Biospace Inc.