Difference between revisions of "Pembrolizumab (Keytruda)"
Jump to navigation
Jump to search
m |
|||
| Line 16: | Line 16: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *9/4/2014: Initial | + | *9/4/2014: Initial [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm accelerated FDA approval] "for the treatment of patients with unresectable or metastatic [[Melanoma|melanoma]] and disease progression following [[Ipilimumab (Yervoy)|ipilimumab]] and, if BRAF V600 mutation positive, a [[:Category:BRAF_inhibitors|BRAF inhibitor]]." |
*10/2/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm465650.htm Accelerated FDA approval] for the treatment of patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after [[:Category:Platinum_agents|platinum-containing]] chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab. | *10/2/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm465650.htm Accelerated FDA approval] for the treatment of patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after [[:Category:Platinum_agents|platinum-containing]] chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab. | ||
| − | *12/18/2015: | + | *12/18/2015: FDA label expanded "for the treatment of patients with unresectable or metastatic [[Melanoma|melanoma]]." |
| − | *8/5/2016: | + | *8/5/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm515627.htm FDA label expanded] "for the treatment of patients with recurrent or metastatic [[Head and neck cancer|head and neck squamous cell carcinoma (HNSCC)]] with disease progression on or after [[:Category:Platinum_agents|platinum-containing]] chemotherapy." |
==Also known as== | ==Also known as== | ||
Revision as of 12:44, 9 August 2016
General information
Class/mechanism: PD-1 antibody. Pembrolizumab is a humanized monoclonal antibody which binds to the PD-1 receptor on T-cells. In some cancers, the PD-1 ligands are upregulated, which results in inhibition of T-cell immune surveillance of tumors. By blocking the interaction between the PD-1 receptor and its ligands PD-L1 and PD-L2, pembrolizumab decreases this immune system inhibition and facilitates anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 9/4/2014: Initial accelerated FDA approval "for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor."
- 10/2/2015: Accelerated FDA approval for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.
- 12/18/2015: FDA label expanded "for the treatment of patients with unresectable or metastatic melanoma."
- 8/5/2016: FDA label expanded "for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy."
Also known as
Lambrolizumab, MK-3475.