KEYTRUDA® (pembrolizumab) in locally advanced unresectable or metastatic oesophageal cancer

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

KEYTRUDA in combination with platinum and fluoropyrimidine-based chemotherapy is indicated for:

Locally advanced unresectable or metastatic oesophageal cancer
For use in The first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumours express PD-L1 Combined Positive Score [CPS] ≥10.1
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 minutes1
Duration of treatment Treat until disease progression or unacceptable toxicity1
Clinical trial KEYNOTE-590 was a phase 3, multicenter, double blinded, active-controlled study of adult patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma, randomised 1:1 to receive pembrolizumab + cisplatin + 5-FU (fluorouracil) or placebo + cisplatin + 5-FU1

Click here to download the KEYNOTE-590 clinical data presentation

Download

Locally advanced unresectable or metastatic oesophageal cancer
For use in The first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 Combined Positive Score [CPS] ≥10. 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 minutes1
Duration of treatment Treat until disease progression or unacceptable toxicity1
Clinical trial KEYNOTE-590 was a phase 3, multicenter, double blinded, active-controlled study of adult patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma, randomised 1:1 to recieve pembrolizumab + Cisplatin + 5-FU (fluorouracil) or Placebo + Cisplatin + 5-FU1

Click here to download the KEYNOTE-590 clinical data presentation

Download

References

  1. KEYTRUDA Summary of Product Characteristics.

Supporting documentation

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GB-PDO-01618 | Date of Preparation: August 2021