All the Active Ingredient Drugs
Monoclonal Antibody. Pembrolizumab 50 mg/vial, 100 mg / 4 ml. Vial. Conc. for sol. for IV inf. 1 X 100 mg/4ml
200 mg every 3 weeks until dis. progress. or unacceptable tox.
See lit.
Melanoma for adlt and ped (12 years and older) with unresectable or metast. melanoma.
Non-Small Cell Lung Cancer, in combin. for the first-line tmt. As a sgle agent, for pts. with advanced NSCLC, with dis. progress. on or after platinum containing chemother. In combin. as neoadjuvant tmt., and then continued as monother. as adjuvant tmt., for resectable NSCLC at high risk of recurrence in adlts. As a sgle agent, as adjuvant tmt. following resection and platinum-based chemother. for adlt pts. with Stage IB, II, or IIIA NSCLC.
Head and Neck Cancer in combin. for the first-line tmt. of metast. or with unresectable, recurrent head and neck squamous cell carcinoma. As a sgle agent for the first-line tmt. of metast. or with unresectable, recurrent HNSCC
Classical Hodgkin Lymphoma for adlt pts with relapsed or refractory classical Hodgkin lymphoma. For the tmt. of ped. pts. with refractory cHL, or cHL that has relapsed after 2 or more lines of ther.
Primary Mediastinal large B-Cell Lymphoma tmt. of adlt. and ped. pts. with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of ther.
Urothelial Cancer in combin. for the first-line tmt of adlt with unresectable or metast. urothelial cancer. As a sgle. agent, for the tmt of pts with locally adv. or metast. urothelial carcinoma. As a sgle agent, for the tmt of pts. with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer with CIS with or w/o papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the tmt. of adult and ped. pts with unresectable or metast., microsatellite instability-high or mismatch repair deficient.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer for the first-line tmt. of pts with unresectable or metast. MSI-H or dMMR colorectal cancer.
Gastric Cancer, in combin. with chemother. for the first-line tmt. of locally advanced unresectable or metast. HER2-positive gastric or GEJ adenocarcinoma in adults. In combin. with chemother. for the first-line tmt. of adults with locally advanced unresectable or metast. HER2-negative gastric or GEJ adenocarcinoma.
Esophageal Cancer for the tmt of pts with locally advanced or metast. esophageal or GEJ (Siewert type I) carcinoma. For the tmt. of pts with recurrent locally advanced or metast. squamous cell carcinoma of the esophagus.
Cervical Cancer in combin. with chemoradiother., for the tmt. of pts with FIGO 2014 Stage III-IVA cervical cancer. In combin. with chemother., with or w/o bevacizumab, for the tmt. of pts with persistent, recurrent, or metast. cervical cancer. As a sgle agent, for the tmt of pts with recurrent or metast. cervical cancer with dis. progres. or after chemother.
Biliary Tract Cancer, In combin. for the tmt of pts with locally advanced unresectable or metast. biliary tract cancer.
Merkel Cell Carcinoma for the tmt. of adult and ped. pts. with recurrent locally advanced or metast. Merkel cell carcinoma.
Renal Cell Carcinoma in combinat. for the first-line tmt of adult pts with advanced RCC. In combin., for the first-line tmt. of adult pts with advanced RCC. For the adjuvant tmt. of pts with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metast. lesions
Endometrial Carcinoma: in combin., followed by this drug as a sgle agent, for adlts with primary advanced or recurrent pMMR endometrial carcinoma at least 12 months from prior adjuvant chemother., and dMMR endometrial carcinoma regardless of prior adjuvant tmt. In combin for advanced or recurrent endometrial carcinoma in adults who have dis. progress. on or following prior tmt. with a platinum-containing ther. and who are not candidates for curative surgery or radiation.
Tumor Mutational Burden-High Cancer for adlts and ped. pts with unresectable or metast. tumor mutational burden-high solid tumors, that have progressed following prior tmt. and who have no satisfact. alternative tmt. options. Limitations of Use: The safety and effectiveness of this drug in ped. pts. with TMB-H central 4 nervous syst. cancers have not been established.
Cutaneous Squamous Cell Carcinoma tmt. of pts with recurrent or metast. cSCC or locally adv. cSCC that is not curable by surgery or radiation
Triple Negative Breast Cancer tmt. of pts. with high-risk early-stage triple-negative breast cancer in combin. with chemother. as neoadjuvant tm., and then continued as a sgle agent as adjuvant tmt. after surgery. In combin. with chemother. for pts. with locally recurrent unresectable or metast. TNBC.
Malignant Pleural Mesothelioma, in combin. with pemetrexed and platinum chemother., indicated for the first line tmt. of adults with unresectable non-epithelioid malignant pleural mesothelioma. See lit.
C/I: Hypersens.
