Keytruda

Keytruda Indications/Uses

pembrolizumab

Manufacturer:

Merck Sharp & Dohme

Distributor:

Merck Sharp & Dohme
Full Prescribing Info
Indications/Uses
Melanoma: Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with unresectable or metastatic melanoma.
Pembrolizumab (KEYTRUDA) is indicated for the treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma who have undergone complete resection.
Pembrolizumab (KEYTRUDA) is indicated for the adjuvant treatment of patients with melanoma with lymph node involvement who have undergone complete resection.
Non-Small Cell Lung Carcinoma: Pembrolizumab (KEYTRUDA), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous non-small cell lung carcinoma (NSCLC), with no EGFR or ALK genomic tumor aberrations.
Pembrolizumab (KEYTRUDA), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
Pembrolizumab (KEYTRUDA) as monotherapy is indicated for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 with a ≥1% tumor proportion score (TPS) as determined by a validated test, with no EGFR or ALK genomic tumor aberrations.
Pembrolizumab (KEYTRUDA) as monotherapy is indicated for the treatment of patients with advanced NSCLC whose tumors express PD-L1 with a ≥1% TPS as determined by a validated test and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have received prior therapy for these aberrations prior to receiving Pembrolizumab (KEYTRUDA).
Small Cell Lung Cancer: Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with locally advanced or metastatic small cell lung cancer (SCLC) who have received two or more prior lines of therapy.
Head and Neck Cancer: Pembrolizumab (KEYTRUDA), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
Pembrolizumab (KEYTRUDA), as monotherapy, is indicated for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma: Pembrolizumab (KEYTRUDA) is indicated for the treatment of adult and pediatric patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
Urothelial Carcinoma: Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, or in patients who are not eligible for any platinum containing chemotherapy regardless of PD-L1 status.
Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.
Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Gastric Cancer: Pembrolizumab (KEYTRUDA), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Pembrolizumab (KEYTRUDA), as monotherapy is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated 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: Pembrolizumab (KEYTRUDA), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction.
Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with recurrent locally advanced or metastatic esophageal cancer whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, and who have received one prior line of systemic therapy.
Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with recurrent locally advanced or metastatic esophageal cancer who have received two or more prior lines of systemic therapy.
Microsatellite Instability-High Cancer: Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with advanced microsatellite instability-high (MSI-H), including mismatch repair deficient (dMMR), cancer who have received prior therapy.
Colorectal Cancer: Pembrolizumab (KEYTRUDA) is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Hepatocellular Carcinoma: Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with an anti-angiogenic tyrosine kinase inhibitor (TKI).
Cervical Cancer: Pembrolizumab (KEYTRUDA), in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Pembrolizumab (KEYTRUDA), as monotherapy, is indicated for the treatment of patients with recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by a validated test, with disease progression on or after chemotherapy.
Renal Cell Carcinoma: Pembrolizumab (KEYTRUDA), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Pembrolizumab (KEYTRUDA), in combination with lenvatinib, is indicated for the first-line treatment of patients with advanced RCC.
Pembrolizumab (KEYTRUDA), as monotherapy, is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Endometrial Carcinoma: Pembrolizumab (KEYTRUDA), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Tumor Mutational Burden-High Cancer: Pembrolizumab (KEYTRUDA) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMBH) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Triple Negative Breast Cancer: Pembrolizumab (KEYTRUDA) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
Pembrolizumab (KEYTRUDA), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by a validated test.
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