Keytruda

Description

What is Keytruda (pembrolizumab) for?

Keytruda (pembrolizumab) is a monoclonal antibody (immunotherapy) indicated for the treatment of people with:

• advanced (unresectable or metastatic) melanoma
• metastatic nonsquamous NSCLC as first-line treatment in combination with pemetrexed and carboplatin
• recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
• recurrent classical Hodgkin Lymphoma (cHL)
• locally advanced or metastatic urothelial carcinoma
• solid tumours having the biomarkers MSI-H or dMMR
• recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

How does Keytruda (pembrolizumab) work?

Keytruda (pembrolizumab) is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body. Keytruda (pembrolizumab) has been designed to attach to and block a receptor called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells, thereby increasing the ability of the immune system to kill cancer cells.

Where has Keytruda (pembrolizumab) been approved?

Keytruda (pembrolizumab) was approved by:

• Food and Drug Administration (FDA), USA:
  • September 4, 2014, for advanced or unresectable melanoma
  • October 2, 2015, for advanced (metastatic) NSCLC which progressed after other treatments and with tumours that express a protein called PD-L
  • August 8, 2016, for recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HBSCC)
  • October 24, 2016, as first-line treatment for metastatic NSCLC with PD-L1 expression on ≥ 50 % of cells as determined by an FDA-approved test; in absence of EGFR or ALK genomic tumour aberrations, and for patients with metastatic NSCLC whose tumours express PD-L1 on ≥ 1 % of cells with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on other therapies approved for these aberrations prior to receiving pembrolizumab
  • March 14, 2017, for adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy
  • May 10, 2017, in combination with pemetrexed and carboplatin, as first-line treatment for metastatic nonsquamous NSCLC
  • May 18, 2017, for locally advanced or metastatic urothelial carcinoma in patients who are not eligible to (first-line treatment) or have disease progression during or following (second-line treatment) certain chemotherapies
  • May 23, 2017, for adult and pediatric patients with unresectable or metastatic solid tumors having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The indication is for tumours that progressed following prior treatment and who have no satisfactory alternative treatment options
  • September 22, 2017, for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (PD-L1 Combined Positive Score (CPS) ≥1), with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
• European Medical Agency (EMA), European Union:
  • July 17, 2015, for advanced or unresectable melanoma
  • June 23, 2016, for locally advanced or metastatic NSCLC
  • January 31, 2017, as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation
  • May 2017, for relapsed or refractory classical Hodgkin lymphoma (cHL)
  • July 20, 2017, for locally advanced or metastatic urothelial carcinoma
• Therapeutic Goods Administration (TGA), Australia:
  • April 16, 2015, for advanced melanoma
  • March 6, 2017, for as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation
  • March 7, 2017, for advanced non-small cell lung carcinoma (NSCLC)
  • March 21, 2017, for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
  • for relapsed or refractory classical Hodgkin Lymphoma (cHL)
  • for locally advanced or metastatic urothelial carcinoma

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Keytruda (pembrolizumab) taken?

The standard dosage is^1,2,3:

• Melanoma: 200 mg every 3 weeks
• NSCLC: 200 mg every 3 weeks
• HNSCC: 200 mg every 3 weeks
• cHL: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
• Urothelial Carcinoma: 200 mg every 3 weeks
• MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for children
• Gastric Cancer: 200 mg every 3 weeks.

Administer as an intravenous infusion over 30 minutes.

Complete information about Keytruda (pembrolizumab) dosage and administration can be found in the official prescribing information listed in our resources section^1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Keytruda (pembrolizumab)?

Common side effects

The most common adverse reactions ( ≥20% of patients) listed in the prescribing information include

• fatigue
• musculoskeletal pain
• decreased appetite
• pruritus
• diarrhea
• nausea
• rash
• pyrexia
• cough
• dyspnea
• constipation.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include

• immune-mediated pneumonitis
• immune-mediated colitis
• immune-mediated hepatitis
• immune-mediated endocrinopathies:
  • Hypophysitis
  • Thyroid disorders
  • Type 1 diabetes mellitus
• immune-mediated nephritis
• immune-mediated skin adverse reactions including, StevensJohnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
• Other immune-mediated adverse reactions: In organ transplant recipients
• Infusion-related reactions
• Complications of allogeneic HSCT.

Use in a specific population

Keytruda (pembrolizumab) can be fatal for a fetus; it is not advised for women who are pregnant or breast feeding

Avoid use in patients with a severely damaged immune system^1,2,3.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information

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