Pembrolizumab

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

Therapeutic indications

Pembrolizumab is indicated for:

Advanced (unresectable or metastatic) melanoma

Population group: only adults (18 - 65 years old)

Pembrolizumab as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

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

200 mg every 3 weeks

400 mg every 6 weeks

Adjuvant treatment of Stage III melanoma and lymph node involvement

Population group: only adults (18 - 65 years old)

Pembrolizumab as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

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

200 mg every 3 weeks

400 mg every 6 weeks

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

Population group: only adults (18 - 65 years old)

Pembrolizumab 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 EGFR or ALK positive tumour mutations.

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

200 mg every 3 weeks

400 mg every 6 weeks

Firstline treatment of metastatic non-squamous NSCLC with no EGFR or ALK positive mutations

Population group: only adults (18 - 65 years old)

Pembrolizumab, in combination with pemetrexed and platinum chemotherapy, is indicated for the firstline treatment of metastatic non-squamous NSCLC 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

First-line treatment of metastatic squamous NSCLC

Population group: only adults (18 - 65 years old)

Pembrolizumab, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.

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

200 mg every 3 weeks

Locally advanced or metastatic NSCLC, with PD-L1 ≥1%, with EGFR or ALK positive mutations

Population group: only adults (18 - 65 years old)

Pembrolizumab as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC 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

400 mg every 6 weeks

Relapsed or refractory classical Hodgkin lymphoma (cHL)

Population group: only adults (18 - 65 years old)

Pembrolizumab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

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

200 mg every 3 weeks

400 mg every 6 weeks

Locally advanced or metastatic urothelial carcinoma

Population group: only adults (18 - 65 years old)

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

400 mg every 6 weeks

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

Population group: only adults (18 - 65 years old)

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

400 mg every 6 weeks

Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), with PD-L1 ≥50%

Population group: only adults (18 - 65 years old)

Pembrolizumab as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) 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

400 mg every 6 weeks

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