FDA recommends pembrolizumab for high-risk, early-stage TNBC
medwireNews: Patients with high-risk, early-stage triple-negative breast cancer (TNBC) may be given pembrolizumab with neoadjuvant chemotherapy and then as monotherapy following surgery, the US FDA has announced.
This approval is based on the findings of the KEYNOTE-522 trial demonstrating significantly better pathologic complete response with pembrolizumab–chemotherapy over chemotherapy alone (63 vs 56%), as well as a significant 37% reduction in the risk for a progression event with the addition of pembrolizumab.
The recommended pembrolizumab dose for this indication is 200 mg every 3 weeks or 400 mg every 6 weeks, to be given for up to 24 weeks alongside neoadjuvant chemotherapy and then as monotherapy for up to 27 weeks in the adjuvant setting.
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