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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cancernetwork.com
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Osimertinib Vs Amivantamab Combos in EGFR/TP53-Mutated NSCLC

Experts discussed treatment options for EGFR or TP53-mutated non–small cell lung cancer, favoring osimertinib or Lazertinib plus amivantamab. They considered patient-specific factors, including mutation types and treatment-related adverse effects, emphasizing the importance of patient preference in choosing aggressive or gentler regimens.
targetedonc.com
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MARIPOSA Trial Shows PFS Benefit With or Without CNS Disease in NSCLC

Amivantamab, an EGFR and MET bispecific, works via ligand blocking, receptor internalization, and immunotherapeutic activity, potentially overcoming TKI resistance in NSCLC. Combined with lazertinib, it showed improved progression-free survival in the MARIPOSA trial vs osimertinib, especially in patients without brain metastases.
cancernetwork.com
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Osimertinib With or Without Chemo is Top Choice for Frontline NSCLC

Osimertinib is the preferred category 1 treatment for EGFR-mutated NSCLC before first-line therapy, according to NCCN guidelines. A University of Chicago panel discussed its first-line use, focusing on FLAURA and FLAURA2 trials. The panel highlighted osimertinib's benefits, including improved progression-free survival (PFS) and overall survival (OS), especially for patients with CNS metastases. The addition of chemotherapy in FLAURA2 further enhanced PFS, particularly for those with baseline brain metastases. However, the regimen's adoption varies, influenced by patient fitness, preferences, and regional practices.
pharmaphorum.com
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AZ posts first-line combo data for lung cancer drug Tagrisso

New data from the FLAURA2 trial indicates combining AstraZeneca's Tagrisso with chemotherapy is more effective than Tagrisso alone in treating EGFR-mutated lung cancer, potentially delaying disease progression. This could extend Tagrisso's label amidst competition from Johnson & Johnson's Rybrevant, with ongoing trials aiming to challenge Tagrisso's dominance.
onclive.com
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The OncFive: Top Oncology Articles for the Week of 12/15

FDA approves encorafenib combo for BRAF V600E+ metastatic CRC, ensartinib for ALK+ NSCLC, issues CRL to subcutaneous amivantamab BLA in EGFR+ NSCLC, seeks EU approval for ibrutinib plus R-CHOP in frontline MCL, and grants breakthrough therapy designation to sacituzumab govitecan for second-line ES-SCLC.
medwatch.com
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FDA delays approval of J&J lung cancer treatment after manufacturing facility inspection

FDA declines approval for J&J's new subcutaneous formulation of lung cancer drug Rybrevant.
targetedonc.com
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FDA Issues CRL for SC Amivantamab BLA in EGFR+ NSCLC

The FDA issued a CRL to Johnson & Johnson's BLA for subcutaneous amivantamab due to manufacturing inspection issues, not efficacy or safety. The CRL does not affect current IV amivantamab approvals. The PALOMA-3 study showed SC amivantamab's comparable efficacy to IV, with shorter administration time and fewer reactions.
biospace.com
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J&J's FDA Bid for Subcutaneous Rybrevant Falls Short

The FDA declined to approve Johnson & Johnson's subcutaneous formulation of Rybrevant for non-small cell lung cancer due to issues detected during a pre-approval inspection, not related to product formulation or efficacy/safety data. J&J aims to resolve the matter quickly.
benzinga.com
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FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer

The FDA issued a CRL to Johnson & Johnson for SC amivantamab in NSCLC patients, citing manufacturing issues, not affecting the approved IV Rybrevant. J&J is working with the FDA for resolution, confident in Rybrevant's efficacy and safety. The BLA is based on Phase 3 PALOMA-3 study results.
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