Difference between revisions of "Amivantamab (Rybrevant)"
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==General information== | ==General information== | ||
| − | Class/mechanism from the NCI Drug Dictionary: A human bispecific antibody targeting both epidermal growth factor receptor EGFR and hepatocyte growth factor receptor (HGFR; cMet), with potential antineoplastic activity. Upon administration, amivantamab simultaneously targets and binds to wild-type or certain mutant forms of both EGFR and cMet expressed on cancer cells, thereby preventing receptor phosphorylation. This prevents the activation of both EGFR- and cMet-mediated signaling pathways. In addition, binding results in receptor degradation, which further inhibits EGFR- and cMet-mediated signaling. JNJ-61186372 also causes antibody-dependent cellular cytotoxicity (ADCC). Altogether, this results in the inhibition of tumor cell proliferation. | + | Class/mechanism from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/amivantamab NCI Drug Dictionary]: A human bispecific antibody targeting both epidermal growth factor receptor EGFR and hepatocyte growth factor receptor (HGFR; cMet), with potential antineoplastic activity. Upon administration, amivantamab simultaneously targets and binds to wild-type or certain mutant forms of both EGFR and cMet expressed on cancer cells, thereby preventing receptor phosphorylation. This prevents the activation of both EGFR- and cMet-mediated signaling pathways. In addition, binding results in receptor degradation, which further inhibits EGFR- and cMet-mediated signaling. JNJ-61186372 also causes antibody-dependent cellular cytotoxicity (ADCC). Altogether, this results in the inhibition of tumor cell proliferation. |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2021-05-21: Granted accelerated approval for adult patients with locally advanced or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with [[Biomarkers#EGFR|epidermal growth factor receptor (EGFR)]] [[Biomarkers#Exon_20|exon 20]] [[Biomarkers#Insertion|insertion mutations]], as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ''(Based on CHRYSALIS)'' |
| + | **2024-03-01: Converted to regular approval for adult patients with locally advanced or metastatic [[Non-small cell lung cancer||NSCLC]] with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ''(Based on PAPILLON)'' | ||
| + | *2024-03-01: Approved with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. ''(Based on PAPILLON)'' | ||
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *12 | + | *2021-12-09: Initial conditional approval as Rybrevant as monotherapy for treatment of adult patients with advanced [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy. |
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| + | ==History of changes in Health Canada indication== | ||
| + | *2022-03-30: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. | ||
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==Also known as== | ==Also known as== | ||
*'''Code name:''' JNJ-61186372 | *'''Code name:''' JNJ-61186372 | ||
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[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
| − | + | [[Category:Anti-EGFR-HGFR bispecific antibodies]] | |
| − | [[Category:Anti-EGFR | ||
| − | |||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
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[[Category:EMA approved in 2021]] | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
| + | [[Category:Health Canada approved in 2022]] | ||
Latest revision as of 00:06, 4 March 2024
General information
Class/mechanism from the NCI Drug Dictionary: A human bispecific antibody targeting both epidermal growth factor receptor EGFR and hepatocyte growth factor receptor (HGFR; cMet), with potential antineoplastic activity. Upon administration, amivantamab simultaneously targets and binds to wild-type or certain mutant forms of both EGFR and cMet expressed on cancer cells, thereby preventing receptor phosphorylation. This prevents the activation of both EGFR- and cMet-mediated signaling pathways. In addition, binding results in receptor degradation, which further inhibits EGFR- and cMet-mediated signaling. JNJ-61186372 also causes antibody-dependent cellular cytotoxicity (ADCC). Altogether, this results in the inhibition of tumor cell proliferation.
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.
Diseases for which it is used
Patient drug information
To be completed
History of changes in FDA indication
- 2021-05-21: Granted accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. (Based on CHRYSALIS)
- 2024-03-01: Converted to regular approval for adult patients with locally advanced or metastatic |NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. (Based on PAPILLON)
- 2024-03-01: Approved with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. (Based on PAPILLON)
History of changes in EMA indication
- 2021-12-09: Initial conditional approval as Rybrevant as monotherapy for treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy.
History of changes in Health Canada indication
- 2022-03-30: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Also known as
- Code name: JNJ-61186372
- Generic name: amivantamab-vmjw
- Brand name: Rybrevant