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 is1,2,3:
- 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 section1,2,3.
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
- musculoskeletal pain
- decreased appetite
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:
- 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 system1,2,3.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information
For more information contact abortpill.com