MedPath

Amivantamab

Generic Name
Amivantamab
Brand Names
Rybrevant
Drug Type
Biotech
Chemical Formula
-
CAS Number
2171511-58-1
Unique Ingredient Identifier
0JSR7Z0NB6
Background

Amivantamab, also known as JNJ-61186372, is an anti-EGFR-MET bispecific antibody, derived from Chinese hamster ovary cells, approved for the treatment of 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. Patients with NSCLC often develop resistance to drugs that target EGFR and MET individually, so amivantamab was developed to attack both targets, reducing the chance of resistance developing. Amivantamab was found to be more effective than the EGFR inhibitor erlotinib or the MET inhibitor crizotinib in vivo. Patients with NSCLC with exon 20 insertion mutations in EGFR do not respond to tyrosine kinase inhibitors, and were generally treated with platinum-based therapy.

Amivantamab was granted FDA approval on 21 May 2021, followed by the approval by the EMA on 9 December 2021 and Health Canada on 30 March 2022.

Indication

Amivantamab is indicated in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Associated Conditions
Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Associated Therapies
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ajmc.com
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FDA Approves Amivantamab for EGFR-Positive NSCLC With Exon 19 Deletion, Exon 21

FDA approves amivantamab-vmjw (Rybrevant) with chemotherapy for EGFR-mutated NSCLC progressing after EGFR TKI treatment. This combination is the only NCCN category 1 option for patients with multiple lesions after osimertinib failure. Phase 3 MARIPOSA-2 study showed improved progression-free survival and overall response rates compared to chemotherapy alone.
healio.com
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FDA approves Rybrevant for advanced lung cancer

FDA approves amivantamab-vmjw (Rybrevant) in combination with chemotherapy for advanced non-small cell lung cancer with EGFR mutations.
pharmaphorum.com
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J&J nets another key approval for blockbuster hope Rybrevant

Johnson & Johnson's Rybrevant (amivantamab) received FDA approval for use with chemotherapy in advanced NSCLC with EGFR exon 19 deletions or L858R mutations, following prior EGFR inhibitor treatment. The MARIPOSA-2 trial showed Rybrevant improved survival rates and progression-free survival compared to chemotherapy alone, though overall survival benefit was not yet statistically significant. Rybrevant aims to address resistance to third-generation EGFR inhibitors like AstraZeneca's Tagrisso.
pharmacytimes.com
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FDA Approves Amivantamab-vmjw for NSCLC With EGFR Exon 19 Deletions or L858R Mutations

FDA approves amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for advanced NSCLC with EGFR mutations, showing improved PFS and ORR in MARIPOSA-2 trial. This combination addresses resistance to EGFR TKIs and offers a new second-line treatment option.
ascopost.com
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FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Non–Small Cell

FDA approved amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, after progression on EGFR tyrosine kinase inhibitor treatment. Efficacy showed median progression-free survival of 6.3 months with amivantamab/CP vs. 4.2 months with CP, and overall response rate of 53% vs. 29%. Common adverse reactions included rash, infusion-related reactions, and fatigue.
curetoday.com
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Rybrevant Plus Chemo Approved by FDA in Lung Cancer Subset

FDA approves Rybrevant plus chemotherapy for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R mutations, based on MARIPOSA-2 trial results showing improved progression-free survival and overall response rate.
prnewswire.com
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RYBREVANT® (amivantamab-vmjw) plus standard of care approved in the U.S. as first and ...

FDA approves RYBREVANT® (amivantamab-vmjw) with chemotherapy for advanced EGFR-mutated NSCLC, based on MARIPOSA-2 study showing 52% reduced risk of disease progression.

Related Clinical Trials:

morningstar.com
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Johnson & Johnson Gets FDA Approval for Non-Small Cell Lung-Cancer Treatment

Johnson & Johnson's Rybrevant approved by FDA for treating locally-advanced or metastatic non-small cell lung cancer in combination with chemotherapy, reducing disease progression risk by 52%.
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