FDA approves pembrolizumab for PD-L1-expressing advanced TNBC
medwireNews: Pembrolizumab has received accelerated approval from the US FDA for use in combination with chemotherapy for the treatment of triple-negative breast cancer (TNBC) patients with locally recurrent unresectable or metastatic disease who test positive for PD-L1 expression.
The decision follows findings from the KEYNOTE-355 trial, which demonstrated a significant improvement in progression-free survival for TNBC patients with a combined positive score for PD-L1 of 10 or higher who were given pembrolizumab plus chemotherapy versus placebo.
The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks before chemotherapy consisting of nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin.
A PD-L1 immunohistochemistry companion diagnostic kit has been approved for use in selection of suitable patients for pembrolizumab therapy.
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