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European Commission Approves Keytruda in Early-Stage Triple-Negative Breast Cancer

This story has been corrected to clarify the approved indication.

NEW YORK – Merck said Tuesday that the European Commission approved its anti-PD-1 therapy Keytruda (pembrolizumab) as a treatment for earlier stages of triple-negative breast cancer.

Keytruda is already available in Europe for locally recurrent, unresectable or metastatic TNBC at risk of recurrence. The new approval will allow TNBC patients with locally advanced or early-stage disease to use Keytruda and chemo before surgery, and then continue with just Keytruda as an adjuvant treatment after surgery.

The European Commission based its decision on results from the Phase III KEYNOTE-522 trial, which showed that patients who received Keytruda-chemo as a neoadjuvant treatment and went on to receive adjuvant Keytruda had a 37 percent reduction in events such as surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause, compared to those who received just neoadjuvant chemotherapy.

Using the same data, the US Food and Drug Administration also approved Keytruda as a neoadjuvant and adjuvant therapy for TNBC in July 2021

With the EC's approval, Merck can market Keytruda in all 27 EU member states, as well as in Iceland, Lichtenstein, Norway, and Northern Ireland.