About KEYTRUDA^®▼ (pembrolizumab)

Prescribing Information

Metastatic NSCLC - first line indications

KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.

Metastatic NSCLC - previously treated indication

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.

ALK: Anaplastic lymphoma kinase; EGFR: Epidermal growth factor receptor.

Melanoma indications

KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

Advanced Urothelial Carcinoma

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥10.

Advanced Renal Cell Carcinoma

KEYTRUDA is indicated in combination with Axitinib for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.

Head and Neck Squamous Cell Carcinoma (HNSCC)

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.

KEYTRUDA in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent HNSCC in adults whose tumours express PD-L1 with a CPS ≥ 1.

Classical Hodgkin Lymphoma (cHL)

KEYTRUDA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

The recommended doses of KEYTRUDA:

• As monotherapy, either 200 mg every 3 weeks or 400 mg every 6 weeks administered intravenously over 30 minutes
• As part of combination therapy, is 200 mg every 3 weeks administered intravenously over 30 minutes. KEYTRUDA should be administered first when given in combination with chemotherapy

Please refer to the KEYTRUDA Summary of Product Characteristics and Risk Minimisation Materials before prescribing KEYTRUDA. Risk Minimisation Materials are available online, from your MSD representative or from MSD Medical Information (Email: medicalinformationuk@merck.com, Phone: 01992 467 272).

KEYTRUDA exerts dual ligand blockade

KEYTRUDA is a selective monoclonal antibody that blocks the programmed cell death-1 (PD-1) protein pathway, potentiating T-cell responses, including anti-tumour responses.^1,2

When functioning properly, T cells are activated and can attack tumour cells^1,2

Some tumours can evade the immune system through the PD-1 pathway. On the surface of tumour cells the dual PD-1 ligands, PD-L1 and PD-L2, bind to the PD-1 receptors on T cells to inactivate them, allowing tumour cells to evade detection^1,2

By inhibiting this process, KEYTRUDA reactivates tumour-specific cytotoxic T lymphocytes and anti-tumour immunity^1,2

PD-1: Programmed cell death-1; PD-L1: Programmed cell death ligand-1; PD-L2: Programmed cell death
ligand-2.

References

1. Harvey, RD. Clin Pharm Therapeutics 2014:96(2):214-223
2. KEYTRUDA Summary of Product Characteristics.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-PDO-00794 | Date of Preparation: January 2020