MSHLPembrolizumab Solution For Infusion 100 mg/4 mL
1) Treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) after receiving platinum-containing chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for locally advanced or metastatic UC. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
2) Pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10) and who have not received prior chemotherapy for metastatic disease. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
3) For untreated metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
4) Monotherapy for untreated unresectable, recurrent or metastatic squamous cell cancer of the head and neck (RMSCCHN) with PD-L1 CPS≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
5) Pembrolizumab in combination with platinum-based chemotherapy, for untreated unresectable, recurrent or metastatic squamous cell cancer of the head and neck (RMSCCHN) with PD-L1 CPS≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
6) For untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1 with a tumour proportion score ≥50%, with no EGFR or ALK genomic tumour aberrations. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
7) Pembrolizumab in combination with platinum-doublet chemotherapy for untreated metastatic squamous non-small cell lung cancer (NSCLC). Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
8) Pembrolizumab in combination with platinum-doublet chemotherapy, for untreated metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumour aberrations. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
9) Treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumours express PD-L1 with a tumour proportion score ≥1% and had disease progression during or following platinum-containing chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for metastatic NSCLC. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
10) Treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL), who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the relapsed or refractory setting. Treatment with pembrolizumab should be stopped at 2 years, or earlier if the person has a stem cell transplant or the disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
11) Adjuvant treatment of completely resected malignant melanoma in patients with lymph node involvement. Maximum duration of treatment: 12 months.
12) Treatment of advanced unresectable or metastatic malignant melanoma. Patients must not have received a PD-1 inhibitor or ipilimumab for advanced unresectable or metastatic malignant melanoma.
13) Pembrolizumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, locally advanced unresectable or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction (GEJ) adenocarcinoma (tumours with epicenter 1 to 5 cm above the GEJ) that is not amenable to surgical resection or definitive chemoradiation. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses.
14) Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
15) Treatment of patients with locally advanced or metastatic urothelial carcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥10, and who are not eligible for cisplatin-containing chemotherapy. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
16) Treatment of advanced unresectable hepatocellular carcinoma (HCC) in patients with disease progression after 1 or more prior lines of systemic therapy, and who have adequate liver function as assessed by the Child-Pugh scoring system. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced unresectable HCC. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
17) Treatment of patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for PMBCL. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression
18) Treatment of metastatic Merkel cell carcinoma. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
19) Treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for the same MSI-H or dMMR solid tumour in the unresectable or metastatic setting. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
20) Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as adjuvant monotherapy after surgery, for previously untreated high-risk, early-stage triple-negative breast cancer. Treatment with pembrolizumab should be stopped after a maximum duration of 1 year across neoadjuvant and adjuvant phases, or earlier if disease progresses or recurs.
21) Pembrolizumab, in combination with chemotherapy, for treating patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 with a CPS ≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
22) Pembrolizumab, in combination with chemotherapy and bevacizumab, for treating patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 with a CPS ≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.
23) Adjuvant treatment of patients with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Maximum duration of treatment: 12 months