Difference between revisions of "Pembrolizumab (Keytruda)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
+ | ===[[Bladder cancer]]=== | ||
+ | *5/18/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm FDA regular approval] for "patients with locally advanced or metastatic [[Bladder cancer|urothelial carcinoma]] who have disease progression during or following [[:Category:Platinum_agents|platinum-containing]] chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with [[:Category:Platinum_agents|platinum-containing]] chemotherapy." | ||
+ | *5/18/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm Granted FDA accelerated approval] for "patients with locally advanced or metastatic [[Bladder cancer|urothelial carcinoma]] who are not eligible for [[Cisplatin (Platinol)|cisplatin-containing]] chemotherapy." | ||
+ | *6/19/2018: FDA label revised for the treatment of patients with locally advanced or metastatic [[bladder cancer|urothelial carcinoma]] who are not eligible for [[Cisplatin (Platinol)|cisplatin-containing]] therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any [[:Category:Platinum_agents|platinum-containing]] chemotherapy regardless of PD-L1 status. | ||
+ | |||
+ | ===[[Cervical cancer]]=== | ||
+ | *6/12/2018: FDA approval expanded "for patients with recurrent or metastatic [[cervical cancer]] with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test." | ||
+ | |||
+ | ===[[Gastric cancer|Gastric or gastroesophageal junction adenocarcinoma]]=== | ||
+ | *9/22/2017: Granted FDA accelerated approval "for patients with recurrent locally advanced or metastatic, [[Gastric cancer|gastric or gastroesophageal junction adenocarcinoma]] whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy." | ||
+ | |||
+ | ===[[Hodgkin lymphoma|Classical Hodgkin lymphoma (cHL)]]=== | ||
+ | *3/14/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558604.htm Granted accelerated FDA approval] "for the treatment of adult and pediatric patients with refractory [[Hodgkin lymphoma|classical Hodgkin lymphoma (cHL)]], or those who have relapsed after three or more prior lines of therapy." | ||
+ | |||
+ | ===[[Head and neck cancer|Head and neck squamous cell carcinoma]]=== | ||
+ | *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." | ||
+ | |||
+ | ===[[Melanoma]]=== | ||
*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]]." | *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]]." | ||
+ | *12/18/2015: FDA label expanded "for the treatment of patients with unresectable or metastatic [[Melanoma|melanoma]]." | ||
+ | |||
+ | ===[[MSI-H or dMMR|MSI-H or dMMR tumors (tissue-agnostic)]]=== | ||
+ | *5/23/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560040.htm Granted FDA accelerated approval] for "adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR [[Colon cancer|colorectal cancer]] that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan." | ||
+ | |||
+ | ===[[Non-small cell lung cancer]]=== | ||
*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. | ||
− | |||
− | |||
*10/24/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm526430.htm FDA label expanded] for the following indications: | *10/24/2016: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm526430.htm FDA label expanded] for the following indications: | ||
**"Patients with metastatic [[Non-small_cell_lung_cancer|NSCLC]] whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC." | **"Patients with metastatic [[Non-small_cell_lung_cancer|NSCLC]] whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC." | ||
**"Patients with metastatic [[Non-small_cell_lung_cancer|NSCLC]] whose tumors express PD-L1 (TPS greater than or equal to 1%) 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." | **"Patients with metastatic [[Non-small_cell_lung_cancer|NSCLC]] whose tumors express PD-L1 (TPS greater than or equal to 1%) 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." | ||
− | |||
*5/10/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558048.htm FDA accelerated approval] to be used "in combination with [[Pemetrexed (Alimta)|pemetrexed]] and [[Carboplatin (Paraplatin)|carboplatin]] for the treatment of patients with previously untreated [[Non-small cell lung cancer|metastatic non-squamous non-small cell lung cancer (NSCLC)]]." | *5/10/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558048.htm FDA accelerated approval] to be used "in combination with [[Pemetrexed (Alimta)|pemetrexed]] and [[Carboplatin (Paraplatin)|carboplatin]] for the treatment of patients with previously untreated [[Non-small cell lung cancer|metastatic non-squamous non-small cell lung cancer (NSCLC)]]." | ||
− | + | ||
− | + | ===[[Primary mediastinal B-cell lymphoma]]=== | |
− | |||
− | |||
− | |||
*6/13/2018: FDA approval expanded "for the treatment of adult and pediatric patients with refractory [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma (PMBCL)]], or who have relapsed after two or more prior lines of therapy." | *6/13/2018: FDA approval expanded "for the treatment of adult and pediatric patients with refractory [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma (PMBCL)]], or who have relapsed after two or more prior lines of therapy." | ||
Revision as of 13:46, 3 July 2018
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
- Bladder cancer
- Cervical cancer
- Colon cancer
- Gastric cancer
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Melanoma
- Merkel cell carcinoma
- MSI-H or dMMR tumors (tissue-agnostic)
- Non-small cell lung cancer
- Primary mediastinal B-cell lymphoma
Patient drug information
- Pembrolizumab (Keytruda) patient drug information (Chemocare)[4]
- Keytruda wallet card about side effects[5]
- Pembrolizumab (Keytruda) patient drug information (UpToDate)[6]
- Pembrolizumab (Keytruda) package insert[1]
Management checklist
- CBC, comprehensive metabolic panel, Mg, Phos, LDH, TSH
History of changes in FDA indication
Bladder cancer
- 5/18/2017: FDA regular approval for "patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy."
- 5/18/2017: Granted FDA accelerated approval for "patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy."
- 6/19/2018: FDA label revised for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
Cervical cancer
- 6/12/2018: FDA approval expanded "for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test."
Gastric or gastroesophageal junction adenocarcinoma
- 9/22/2017: Granted FDA accelerated approval "for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy."
Classical Hodgkin lymphoma (cHL)
- 3/14/2017: Granted accelerated FDA approval "for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy."
Head and neck squamous cell carcinoma
- 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."
Melanoma
- 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."
- 12/18/2015: FDA label expanded "for the treatment of patients with unresectable or metastatic melanoma."
MSI-H or dMMR tumors (tissue-agnostic)
- 5/23/2017: Granted FDA accelerated approval for "adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan."
Non-small cell lung cancer
- 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.
- 10/24/2016: FDA label expanded for the following indications:
- "Patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC."
- "Patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1%) 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."
- 5/10/2017: FDA accelerated approval to be used "in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC)."
Primary mediastinal B-cell lymphoma
- 6/13/2018: FDA approval expanded "for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy."
Also known as
- Code names: MK-3475, SCH 900475
- Generic names: lambrolizumab
- Brand name: Keytruda
References
- ↑ 1.0 1.1 1.2 Pembrolizumab (Keytruda) package insert
- ↑ Pembrolizumab (Keytruda) package insert (locally hosted backup)
- ↑ Keytruda manufacturer's website
- ↑ Pembrolizumab (Keytruda) patient drug information (Chemocare)
- ↑ Keytruda wallet card about side effects
- ↑ Pembrolizumab (Keytruda) patient drug information (UpToDate)
- Drugs
- Intravenous medications
- Mutation-specific medications
- Immunotherapy
- T-cell activators
- Antibody medications
- Anti-PD-1 antibodies
- Bladder cancer medications
- Cervical cancer medications
- Colon cancer medications
- Gastric cancer medications
- Head and neck cancer medications
- Hodgkin lymphoma medications
- Melanoma medications
- Merkel cell carcinoma medications
- MSI-H or dMMR medications
- Non-small cell lung cancer medications
- Primary mediastinal B-cell lymphoma medications
- Drugs FDA approved in 2014
- EMA approved drugs
- PMDA approved drugs