Keytruda (pembrolizumab)

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
• advanced renal cell carcinoma (RCC)
• locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1.

It is available as a powder for intravenous infusion (drip) containing 100mg of pembrolizumab per vial.

Note: Keytruda (pembrolizumab) is currently only available in 100mg form (100mg/4ml). There used to be a 50mg presentation but this has been discontinued as of March 15th, 2019.

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 as an onocology medicine 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
  • November 13, 2020, in combination with chemotherapy for patients with TNBC.
• 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
• Health Canada, January 15, 2019^[19]:
  • Unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy
  • Unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor
  • Metastatic non-small cell lung carcinoma (NSCLC) as monotherapy, in adults whose tumours have high PD-L1 expression (TPS ≥50%) as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC
  • Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinumcontaining chemotherapy
• Medsafe, New Zealand:
  • for unresectable or metastatic melanoma in adults and the adjuvant treatment of patients with melanoma with lymph node involvement who have undergone complete resection
  • for locally advanced or metastatic NSCLC
  • relapsed or refractory classical Hodgkin lymphoma (cHL)
  • for locally advanced or metastatic urothelial carcinoma
  • for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy
  • in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
  • in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours that have progressed following prior treatment and when there are no satisfactory alternative treatment options
  • in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Please note that this medication 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 for assistance.

Please be aware that any decision to use a prescription brand-name or (cheap) generic medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to wholesale distributors in India concerning the quality of their medicines.

How is Keytruda (pembrolizumab) taken?

The standard dosage is

• 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 200mg) 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.

For children with cHL and MSI-H, how much Keytruda (pembrolizumab) is needed depends on the body weight.

Complete information about Keytruda (pembrolizumab) dose and administration can be found in the official prescribing information listed in our references section

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

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