Amivantamab: First Approval
Amivantamab (amivantamab-vmjw; Rybrevant™), a bispecific monoclonal antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET), is being developed by Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). On 21 May 2021, amivantama...
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| Veröffentlicht in: | Drugs (New York, N.Y.) N.Y.), 2021-07, Vol.81 (11), p.1349-1353 |
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| creator | Syed, Yahiya Y. |
| description | Amivantamab (amivantamab-vmjw; Rybrevant™), a bispecific monoclonal antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET), is being developed by Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC. |
| doi_str_mv | 10.1007/s40265-021-01561-7 |
| format | Article |
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On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC.</description><identifier>ISSN: 0012-6667</identifier><identifier>EISSN: 1179-1950</identifier><identifier>DOI: 10.1007/s40265-021-01561-7</identifier><identifier>PMID: 34292533</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>AdisInsight Report ; Antibodies, Bispecific - adverse effects ; Antibodies, Bispecific - pharmacokinetics ; Antibodies, Bispecific - pharmacology ; Antibodies, Bispecific - therapeutic use ; Antineoplastic Agents, Immunological - adverse effects ; Antineoplastic Agents, Immunological - pharmacokinetics ; Antineoplastic Agents, Immunological - pharmacology ; Antineoplastic Agents, Immunological - therapeutic use ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - pathology ; Chemotherapy ; Collaboration ; Disease ; Drug Approval ; Dyspnea ; Epidermal growth factor ; Epidermal growth factor receptors ; ErbB Receptors - drug effects ; ErbB Receptors - genetics ; Growth factors ; Humans ; Internal Medicine ; Kinases ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - pathology ; Medicine ; Medicine & Public Health ; Mesenchyme ; Metastases ; Metastasis ; Monoclonal antibodies ; Multicenter Studies as Topic ; Mutation ; Neoplasm Metastasis ; Neoplasm Staging ; Non-small cell lung carcinoma ; Patients ; Pharmacology/Toxicology ; Pharmacotherapy ; Platinum ; Pneumonia ; Randomized Controlled Trials as Topic ; Regulatory approval ; Small cell lung carcinoma ; Targeted cancer therapy ; United States ; United States Food and Drug Administration</subject><ispartof>Drugs (New York, N.Y.), 2021-07, Vol.81 (11), p.1349-1353</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG 2021</rights><rights>2021. 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On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC.</description><subject>AdisInsight Report</subject><subject>Antibodies, Bispecific - adverse effects</subject><subject>Antibodies, Bispecific - pharmacokinetics</subject><subject>Antibodies, Bispecific - pharmacology</subject><subject>Antibodies, Bispecific - therapeutic use</subject><subject>Antineoplastic Agents, Immunological - adverse effects</subject><subject>Antineoplastic Agents, Immunological - pharmacokinetics</subject><subject>Antineoplastic Agents, Immunological - pharmacology</subject><subject>Antineoplastic Agents, Immunological - therapeutic use</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Chemotherapy</subject><subject>Collaboration</subject><subject>Disease</subject><subject>Drug Approval</subject><subject>Dyspnea</subject><subject>Epidermal growth factor</subject><subject>Epidermal growth factor receptors</subject><subject>ErbB Receptors - drug effects</subject><subject>ErbB Receptors - genetics</subject><subject>Growth factors</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Kinases</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - pathology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mesenchyme</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Monoclonal antibodies</subject><subject>Multicenter Studies as Topic</subject><subject>Mutation</subject><subject>Neoplasm Metastasis</subject><subject>Neoplasm Staging</subject><subject>Non-small cell lung carcinoma</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Platinum</subject><subject>Pneumonia</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Regulatory approval</subject><subject>Small cell lung carcinoma</subject><subject>Targeted cancer therapy</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>0012-6667</issn><issn>1179-1950</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kE1LAzEQhoModq3-AQUpePESzeRz11spVoWCl95DspuVLftRk92C_97UrQoePA3DPPPO8CB0CeQOCFH3gRMqBSYUMAEhAasjlACoDEMmyDFKCAGKpZRqgs5C2OzbTGSnaMI4zahgLEFX86bambY3jbEPs2XlQz-bb7e-25n6HJ2Upg7u4lCnaL18XC-e8er16WUxX-GcKdFjA4xIB4oDpValxpXWGsetBKqYhYKbwjpaxpeKrASWEgeECVcKx4tclWyKbsfYePV9cKHXTRVyV9emdd0QNBWCM0EJpxG9-YNuusG38bk9JdNUKZlGio5U7rsQvCv11leN8R8aiN6b06M5Hc3pL3NaxaXrQ_RgG1f8rHyrigAbgRBH7Zvzv7f_if0EhWR2YQ</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Syed, Yahiya Y.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7QO</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20210701</creationdate><title>Amivantamab: First Approval</title><author>Syed, Yahiya Y.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-a1306e174122b78aefbbae4b61273b1d4adbe2f950d9f1380e1035ef5e4dc7f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>AdisInsight Report</topic><topic>Antibodies, Bispecific - adverse effects</topic><topic>Antibodies, Bispecific - pharmacokinetics</topic><topic>Antibodies, Bispecific - pharmacology</topic><topic>Antibodies, Bispecific - therapeutic use</topic><topic>Antineoplastic Agents, Immunological - adverse effects</topic><topic>Antineoplastic Agents, Immunological - pharmacokinetics</topic><topic>Antineoplastic Agents, Immunological - pharmacology</topic><topic>Antineoplastic Agents, Immunological - therapeutic use</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Chemotherapy</topic><topic>Collaboration</topic><topic>Disease</topic><topic>Drug Approval</topic><topic>Dyspnea</topic><topic>Epidermal growth factor</topic><topic>Epidermal growth factor receptors</topic><topic>ErbB Receptors - drug effects</topic><topic>ErbB Receptors - genetics</topic><topic>Growth factors</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Kinases</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - 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On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>34292533</pmid><doi>10.1007/s40265-021-01561-7</doi><tpages>5</tpages></addata></record> |
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| ispartof | Drugs (New York, N.Y.), 2021-07, Vol.81 (11), p.1349-1353 |
| issn | 0012-6667 1179-1950 |
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| subjects | AdisInsight Report Antibodies, Bispecific - adverse effects Antibodies, Bispecific - pharmacokinetics Antibodies, Bispecific - pharmacology Antibodies, Bispecific - therapeutic use Antineoplastic Agents, Immunological - adverse effects Antineoplastic Agents, Immunological - pharmacokinetics Antineoplastic Agents, Immunological - pharmacology Antineoplastic Agents, Immunological - therapeutic use Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - pathology Chemotherapy Collaboration Disease Drug Approval Dyspnea Epidermal growth factor Epidermal growth factor receptors ErbB Receptors - drug effects ErbB Receptors - genetics Growth factors Humans Internal Medicine Kinases Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - pathology Medicine Medicine & Public Health Mesenchyme Metastases Metastasis Monoclonal antibodies Multicenter Studies as Topic Mutation Neoplasm Metastasis Neoplasm Staging Non-small cell lung carcinoma Patients Pharmacology/Toxicology Pharmacotherapy Platinum Pneumonia Randomized Controlled Trials as Topic Regulatory approval Small cell lung carcinoma Targeted cancer therapy United States United States Food and Drug Administration |
| title | Amivantamab: First Approval |
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