Pembrolizumab

Chemical formula: C6534H10004N1716O2036S46 Molecular mass: 149,000 g/mol

Therapeutic indications

Pembrolizumab is indicated for:

Advanced (unresectable or metastatic) melanoma

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Pembrolizumab as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

2 mg/kg bodyweight every 3 weeks

Stage IIB, IIC or III melanoma

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Pembrolizumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

2 mg/kg bodyweight every 3 weeks

First-line treatment of metastatic non-small cell lung carcinoma with PD-L1 ≥50%, with no EGFR or ALK positive mutations

Population group: only adults (18 years old or older)

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

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of metastatic non-squamous non-small cell lung carcinoma with no EGFR or ALK positive mutations

Population group: only adults (18 years old or older)

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

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of metastatic squamous non-small cell lung carcinoma

Population group: only adults (18 years old or older)

Pembrolizumab, 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 in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Locally advanced or metastatic non-small cell lung carcinoma, with PD-L1 ≥1%, with EGFR or ALK positive mutations

Population group: only adults (18 years old or older)

Pembrolizumab as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma 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 pembrolizumab.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Relapsed or refractory classical Hodgkin lymphoma

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Pembrolizumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

2 mg/kg bodyweight every 3 weeks

Locally advanced or metastatic urothelial carcinoma

Population group: only adults (18 years old or older)

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

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Locally advanced or metastatic urothelial carcinoma with PD-L1 with CPS ≥10

Population group: only adults (18 years old or older)

Pembrolizumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Recurrent or metastatic head and neck squamous cell carcinoma with PD-L1 with a ≥50% TPS

Population group: only adults (18 years old or older)

Pembrolizumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Resectable non-small cell lung carcinoma at high risk of recurrence

Population group: only adults (18 years old or older)

Pembrolizumab, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

4 doses of 200 mg every 3 weeks or 2 doses of 400 mg every 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment

Non-small cell lung carcinoma at high risk of recurrence following complete resection and chemotherapy

Population group: only adults (18 years old or older)

Pembrolizumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of unresectable or metastatic urothelial carcinoma

Population group: only adults (18 years old or older)

Pembrolizumab, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma with PD-L1 with a CPS ≥1

Population group: only adults (18 years old or older)

Pembrolizumab, 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 head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥1.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of advanced renal cell carcinoma in combination with axitinib

Population group: only adults (18 years old or older)

Pembrolizumab, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of advanced renal cell carcinoma in combination with lenvatinib

Population group: only adults (18 years old or older)

Pembrolizumab, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Renal cell carcinoma in patients at increased risk of recurrence following nephrectomy

Population group: only adults (18 years old or older)

Pembrolizumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Colorectal cancer with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers

Population group: only adults (18 years old or older)

Pembrolizumab as monotherapy is indicated for adults with MSI-H or 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Non-colorectal cancers with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers

Population group: only adults (18 years old or older)

Pembrolizumab as monotherapy is indicated for the treatment of the following MSI-H or 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of locally advanced unresectable or metastatic carcinoma with PD-L1 with a CPS ≥10

Population group: only adults (18 years old or older)

Pembrolizumab, 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence

Population group: only adults (18 years old or older)

Pembrolizumab, 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks or until disease progress ion that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment

Locally recurrent unresectable or metastatic triple-negative breast cancer with PD-L1 with a CPS ≥10

Population group: only adults (18 years old or older)

Pembrolizumab, 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Endometrial carcinoma

Population group: only adults (18 years old or older)

Pembrolizumab, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have dise ase progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Persistent, recurrent, or metastatic cervical cancer with PD-L1 with a CPS ≥1

Population group: only adults (18 years old or older)

Pembrolizumab, 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of HER2-positive gastric or gastro-oesophageal junction adenocarcinoma with PD-L1 with a CPS ≥1

Population group: only adults (18 years old or older)

Pembrolizumab, 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of HER2-negative gastric or gastro-oesophageal junction adenocarcinoma with PD-L1 with a CPS ≥1

Population group: only adults (18 years old or older)

Pembrolizumab, 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

First-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma

Population group: only adults (18 years old or older)

Pembrolizumab, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

200 mg every 3 weeks or 400 mg every 6 weeks

Contraindications

Pembrolizumab is contraindicated in the following cases:

Lactation

Lactation

< Previous: Overview

Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈