Difference between revisions of "Pembrolizumab (Keytruda)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *9/4/2014: Initial accelerated [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm FDA approval] "for the treatment of patients with unresectable or [[Melanoma | | + | *9/4/2014: Initial accelerated [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm 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. | ||
Revision as of 19:00, 5 October 2015
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]
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.
Also known as
Lambrolizumab, MK-3475.