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 PEMBROLIZUMAB

Keytruda may be considered medically necessary in patients with:
Labeled Indications:

Melanoma:

Adjuvant treatment of melanoma with lymph node(s) involvement following complete resection

Treatment of unresectable or metastatic melanoma

Non-small cell lung cancer:

First-line, single-agent treatment of non-small cell lung cancer (NSCLC) in patients with stage III NSCLC (who are not candidates for surgical resection or definitive chemoradiation) or in patients with metastatic NSCLC, and with tumors with PD-L1 expression (tumor proportion score [TPS] ≥1%), as determined by an approved test, and with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations

First-line treatment (in combination with pemetrexed and platinum chemotherapy) of metastatic nonsquamous NSCLC in patients with no EGFR or ALK genomic tumor aberrations

First-line treatment (in combination with carboplatin and either paclitaxel or paclitaxel [protein bound]) of metastatic squamous NSCLC

Single-agent treatment of metastatic NSCLC in patients with tumors with PD-L1 expression (TPS ≥1%), as determined by an approved test, and with disease progression on or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression (on approved EGFR- or ALK-directed therapy) prior to receiving pembrolizumab.

Off-label dosing (in patients with metastatic non-small cell lung cancer (NSCLC) with disease progression following platinum-containing chemotherapy): 2 mg/kg once every 3 weeks for 24 months or until disease progression or unacceptable toxicity (Herbst 2016).

Small cell lung cancer (metastatic): Treatment of metastatic small cell lung cancer in patients with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy

Head and neck cancer, squamous cell (recurrent or metastatic):

First-line treatment (in combination with platinum and fluorouracil) of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC)

First-line, single-agent treatment of metastatic or unresectable recurrent HNSCC in patients whose tumors express PD-L1 (CPS ≥1), as determined by an approved test

Single-agent treatment of recurrent or metastatic HNSCC in patients with disease progression on or after platinum-containing chemotherapy

Hodgkin lymphoma, classical (relapsed or refractory): Treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or patients who have relapsed after 3 or more prior lines of therapy

Primary mediastinal large B-cell lymphoma (relapsed or refractory): Treatment of primary mediastinal large B-cell lymphoma (PMBCL) in adult and pediatric patients with refractory disease or who have relapsed after 2 or more prior lines of therapy

Limitation of use: Not recommended for treatment of PMBCL in patients who require urgent cytoreductive therapy

Urothelial carcinoma (locally advanced or metastatic):

Treatment of locally advanced or metastatic urothelial cancer in patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10) as determined by an approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status

Treatment of locally advanced or metastatic urothelial cancer in patients with disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy

Microsatellite instability-high cancer (unresectable or metastatic):

Solid tumors: Treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors in adult and pediatric patients that have progressed following prior treatment and have no satisfactory alternate treatment options.

Limitation of use: Safety and efficacy in pediatric patients with MSI-H central nervous system cancers have not been established.

Colorectal cancer: Treatment of unresectable or metastatic, MSI-H or mismatch repair deficient colorectal cancer in adult and pediatric patients that have progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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Gastric cancer /  (recurrent locally advanced or metastatic): Treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients whose tumors express PD-L1 (CPS ≥1), as determined by an approved test, 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

Esophageal cancer (recurrent locally advanced or metastatic): Treatment of recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus in patients whose tumors express PD-L1 (CPS ≥10) as determined by an approved test, with disease progression after one or more prior lines of systemic therapy.  Pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.

Cervical cancer (recurrent or metastatic): Treatment of recurrent or metastatic cervical cancer in patients whose tumors express PD-L1 (combined positive score [CPS] ≥1), as determined by an approved test, and with disease progression on or after chemotherapy

Hepatocellular carcinoma (advanced): Treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib

Merkel cell carcinoma (recurrent or metastatic): Treatment of recurrent locally advanced or metastatic Merkel cell carcinoma in adult and pediatric patients

Renal cell carcinoma (advanced): First-line treatment of advanced renal cell carcinoma (in combination with axitinib)

Endometrial carcinoma (advanced): Treatment of advanced endometrial carcinoma (in combination with lenvatinib) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

Cutaneous squamous cell carcinoma (recurrent or metastatic): IV: 200 mg once every 3 weeks or 400 mg once every 6 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to 24 months. FDA 6/24/2020

Tumor mutational burden-high cancer (unresectable or metastatic): IV: 200 mg once every 3 weeks or 400 mg once every 6 weeks; continue until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to 24 months. FDA 6/18/2020

Breast Cancer, Triple Negative, (unresectable or metastatic)

On Nov. 13, 2020, the U.S. Food and Drug Administration (FDA) approved the immunotherapy Keytruda (chemical name: pembrolizumab) in combination with chemotherapy to treat unresectable locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.

Pembrolizumab (Keytruda) is recommended by the NCCN Drugs and Biologics Compendium® for off-label use for the following indication:

Chondrosarcoma – as a single agent for unresectable or metastatic, deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H), and tumor mutational burden-high (TMB-H) conventional chondrosarcoma, dedifferentiated chondrosarcoma, and mesenchymal chondrosarcoma that have progressed following prior treatment in patients who have no satisfactory alternative treatment options
Chordoma – as a single agent for unresectable or metastatic, tumor mutational burden-high (TMB-H) disease that has progressed following prior treatment in patients who have no satisfactory alternative treatment options
Classic Hodgkin lymphoma – as single agent, palliative therapy for disease that has relapsed or progressed after autologous hematopoietic stem cell transplant with or without brentuximab vedotin, for relapsed/refractory disease and transplant ineligible based on comorbidity or failure of second-line chemotherapy, or post-allogeneic transplant in individuals older than age 60
CNS – Brain metastases (limited) – as a single agent for limited brain metastases in patients with melanoma or PD-L1-positive non-small cell lung cancer as initial treatment in select patients, as treatment for recurrent brain metastases, or as treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options
CNS – Brain metastases (extensive) – as a single agent for extensive brain metastases in patients with melanoma or PD-L1-positive non-small cell lung cancer as primary treatment in select patients or as treatment for recurrent disease with stable systemic disease or reasonable systemic treatment options
High-grade undifferentiated pleomorphic sarcoma of the bone – as a single agent for unresectable or metastatic deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumors that have progressed following prior treatment in patients who have no satisfactory alternative treatment options
Mesenchymal chondrosarcoma – as a single agent for unresectable or metastatic deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumors that have progressed following prior treatment in patients who have no satisfactory alternative treatment options
Pancreatic cancer – single agent, first-line therapy for deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) metastatic disease in patients with poor performance status
Pancreatic cancer – as a single agent, subsequent-line therapy for microsatellite instability-high or mismatch repair deficient tumors) for locally advanced or metastatic disease for patients with disease progression
Pancreatic cancer – as a single agent for microsatellite instability-high or mismatch repair deficient tumors for local recurrence in the pancreatic operative bed after resection, metastatic disease with or without local recurrence if 6 or more months from completion of primary therapy, or metastatic disease with or without local recurrence if less than 6 months from completion of primary therapy
Penile cancer (squamous cell) – as a single agent for deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H), metastatic or unresectable tumors that have progressed following prior treatment in patients with no satisfactory alternative treatment options
Poorly differentiated/large or small cell neuroendocrine and adrenal tumors – as a single agent for deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumors when disease progressed following prior treatment and when there is no satisfactory alternative treatment options
Poorly differentiated/large or small cell neuroendocrine and adrenal tumors – as a single agent in children for mutational burden-high (≥ 10 mutations/megabase), metastatic or unresectable tumors that have progressed following prior treatment in patients with no satisfactory alternative treatment options
Renal cell cancer (clear cell histology) – as first-line therapy in combination with axitinib for advance disease
Renal cell cancer (clear cell histology) – as subsequent therapy in combination with axitinib for relapse or stage IV disease
Uterine Sarcoma – as single agent, second-line therapy for tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] in patients with high-grade endometrial stroma sarcoma, undifferentiated uterine sarcoma, and uterine leiomyosarcoma in patients whose disease progressed following prior treatment and in whom no satisfactory alternative treatment options exist

Keytruda is considered investigational in patients with all other indications.

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