About KEYTRUDA
KEYTRUDA (pembrolizumab) 25 mg/mL Concentrate Solution for Infusion Prescribing Information [External link] | Resources | Adverse Event Reporting
Always refer to the full Summary of Product Characteristics before prescribing for up-to-date and complete safety considerations to help minimise the risks associated with the use of KEYTRUDA.
KEYTRUDA Selected Licensed indications
First-line indications
KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then monotherapy as adjuvant treatment for resectable non-small cell lung carcinoma NSCLC at high risk of recurrence in adults.
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma (NSCLC) in adults.
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (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 epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy.
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 epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma (aRCC) in adults.
KEYTRUDA is indicated in combination with axitinib for the first-line treatment of advanced renal cell carcinoma (aRCC) in adults.
KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection.
KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥10 and who have not received prior chemotherapy for metastatic disease.
KEYTRUDA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults.
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting, and who are not candidates for curative surgery or radiation.
KEYTRUDA as monotherapy is indicated for adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in the following settings:
- first-line treatment of metastatic colorectal cancer;
- treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.
KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥10.
KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥1.
KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥1.
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent (M/uR) head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥1.
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing chemotherapy.
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1.
KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1.
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.
KEYTRUDA, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults
KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT is not a treatment option.
KEYTRUDA as monotherapy is indicated for the treatment of the following microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours in adults with:
- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
KEYTRUDA offers flexibility of dosing2
Assessment of regimens
The 200 mg Q3W (once every 3 weeks) regimen has been assessed in phase 2 and 3 registration studies across a multitude of indications of KEYTRUDA. An exposure-response evaluation, using modelling and simulation, led to the approval of the 400 mg Q6W (once every 6 weeks) dosing for monotherapy and combination therapy.2
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@msd.com, Phone: 0208 154 8000).
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.2,3
Normal immune response
When functioning properly, T cells are activated and can attack tumour cells2,3
Tumour evasion and T cells
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 detection2,3
T-cell reactivation with KEYTRUDA
By inhibiting this process, KEYTRUDA reactivates tumour-specific cytotoxic T lymphocytes and anti-tumour immunity2,3
PD-1 = Programmed Cell Death-1; PD-L1 = Programmed Cell Death Ligand-1; PD-L2 = Programmed Cell Death Ligand-2.
References
- KEYTRUDA (pembrolizumab) Solution for Injection Summary of Product Characteristics (395 and 790mg).
- KEYTRUDA (pembrolizumab) 25 mg/mL Concentrate Solution for Infusion Summary of Product Characteristics.
- Harvey, RD. Clin Pharm Therapeutics. 2014:96(2):214-223.
Supporting documentation
KEYTRUDA 25 mg/mL concentrate for solution for infusion Prescribing Information (United Kingdom) [External link]
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