Difference between revisions of "Nivolumab (Opdivo)"
Jump to navigation
Jump to search
(updated content) |
(added reference) |
||
| Line 15: | Line 15: | ||
# Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma. N Engl J Med. 2014 Dec 6. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1411087 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25482239 PubMed] | # Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma. N Engl J Med. 2014 Dec 6. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1411087 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/25482239 PubMed] | ||
| + | ===[[Non-small cell lung cancer]]=== | ||
| + | # Bristol-Myers Squibb: [http://news.bms.com/press-release/checkmate-017-phase-3-study-opdivo-nivolumab-compared-docetaxel-patients-second-line-s CheckMate -017, A Phase 3 Study of Opdivo (Nivolumab) Compared to Docetaxel in Patients with Second-Line Squamous Cell Non-small Cell Lung Cancer, Stopped Early]. Patients in the study receiving nivolumab had superior overall survival compared to patients in the control arm who received docetaxel 75 mg/m2 intravenously every three weeks. | ||
| + | |||
==Patient drug information== | ==Patient drug information== | ||
*[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]<ref name="insert"></ref> | *[http://packageinserts.bms.com/pi/pi_opdivo.pdf Nivolumab (Opdivo) package insert]<ref name="insert"></ref> | ||
| Line 20: | Line 23: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*12/22/2014: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427716.htm FDA approved] "for the treatment of patients with unresectable or metastatic [[melanoma]] and disease progression following [[Ipilimumab (Yervoy)|ipilimumab]] and, if BRAF V600 mutation positive, a [[:Category:BRAF inhibitors|BRAF inhibitor]]." | *12/22/2014: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427716.htm FDA approved] "for the treatment of patients with unresectable or metastatic [[melanoma]] and disease progression following [[Ipilimumab (Yervoy)|ipilimumab]] and, if BRAF V600 mutation positive, a [[:Category:BRAF inhibitors|BRAF inhibitor]]." | ||
| − | *3/4/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm FDA approved] "for the treatment of patients with metastatic squamous [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with progression on or after platinum-based chemotherapy." | + | *3/4/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436566.htm FDA approved] "for the treatment of patients with metastatic squamous [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with progression on or after [[:Category:Platinum agents|platinum-based chemotherapy]]." |
==Also known as== | ==Also known as== | ||
Revision as of 22:21, 4 March 2015
General information
Class/mechanism: PD-1 receptor antibody. Nivolumab is an IgG4 kappa human monoclonal antibody which binds to the PD-1 (programmed death receptor-1) receptor and blocks its interaction with the ligands PD-L1 and PD-L2. Normally, PD-L1 and PD-L2 binding to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production, which can impede immune system surveillance of tumors. By interfering with the binding of PD-L1 and PD-L2 to the PD-1 receptor, nivolumab can cause upregulation of the 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
Preliminary data
Hodgkin lymphoma
- Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin's Lymphoma. N Engl J Med. 2014 Dec 6. [Epub ahead of print] link to original article PubMed
Non-small cell lung cancer
- Bristol-Myers Squibb: CheckMate -017, A Phase 3 Study of Opdivo (Nivolumab) Compared to Docetaxel in Patients with Second-Line Squamous Cell Non-small Cell Lung Cancer, Stopped Early. Patients in the study receiving nivolumab had superior overall survival compared to patients in the control arm who received docetaxel 75 mg/m2 intravenously every three weeks.
Patient drug information
History of changes in FDA indication
- 12/22/2014: FDA approved "for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor."
- 3/4/2015: FDA approved "for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy."
Also known as
BMS-936558, MDX-1106.