KEYTRUDA® (pembrolizumab) in triple-negative breast cancer (TNBC)

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

KEYTRUDA in combination with chemotherapy is indicated for:

Locally recurrent unresectable or metastatic triple‑negative breast cancer
For use in The first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥10 and who have not received prior chemotherapy for metastatic disease.1
Dosing schedule The recommended dose is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.1
Duration of treatment Treat until disease progression or unacceptable toxicity.1
Clinical trial KEYNOTE-355 was a phase 3 multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of KEYTRUDA in combination with paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin in patients with locally recurrent unresectable or metastatic TNBC, regardless of tumour PD-L1 expression, who had not been previously treated with chemotherapy plus placebo in the metastatic setting.1

Click here to download the KEYNOTE-355 clinical data presentation

Download

Locally recurrent unresectable or metastatic triple‑negative breast cancer
For use in The first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥10 and who have not received prior chemotherapy for metastatic disease.1
Dosing schedule The recommended dose is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.1
Duration of treatment Treat until disease progression or unacceptable toxicity.1
Clinical trial KEYNOTE-355 was a phase 3 multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of KEYTRUDA in combination with paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin in patients with locally recurrent unresectable or metastatic TNBC, regardless of tumour PD-L1 expression, who had not been previously treated with chemotherapy in the metastatic setting.1

Click here to download the KEYNOTE-355 clinical data presentation

Download

Refer to the Summary of Product Characteristics and Risk Minimisation materials available on the emc website before prescribing in order to help reduce the risk associated with KEYTRUDA.

Reference

  1. KEYTRUDA Summary of Product Characteristics.

Supporting documentation

By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-PDO-01875 | Date of Preparation: January 2022