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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rttnews.com
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Phase 3 Data Show RYBREVANT + LAZCLUZE Outperforms Osimertinib In Non-small

Johnson & Johnson announced that the MARIPOSA study showed RYBREVANT combined with LAZCLUZE provided consistent long-term benefits over osimertinib in advanced NSCLC patients with EGFR exon 19 deletions or L858R mutations, with 61% survival at three years compared to 53% for osimertinib.
onclive.com
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Dr Spira on Updated MARIPOSA Trial Data in EGFR+ Advanced NSCLC

Alexander Spira discusses MARIPOSA study findings showing amivantamab-vmjw plus lazertinib significantly improves progression-free survival vs osimertinib in EGFR-mutated NSCLC. FDA approved the combination in 2024. Longer-term data from 2024 IASLC World Conference on Lung Cancer indicates potential overall survival benefit with the doublet.
cancerletter.com
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FDA approves Rybrevant + Lazcluze for NSCLC

Effective immediately, card will be charged a prorated amount based on existing subscription level. Options: OK or Cancel.
rybrevanthcp.com
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RYBREVANT® (amivantamab-vmjw) HCP

RYBREVANT® + LAZCLUZE™ approved for first-line treatment of EGFR+ NSCLC, showing significant mPFS improvement over osimertinib.
biopharmadive.com
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J&J drug combo for lung cancer approved by FDA

FDA approved Johnson & Johnson's Rybrevant with Lazcluze for untreated, advanced non-small cell lung cancer with specific EGFR mutations. This chemotherapy-free regimen showed a 30% lower risk of cancer progression or death compared to AstraZeneca's Tagrisso, despite higher side effects. Patients require prophylactic anticoagulation due to safety concerns.
aptitudehealth.com
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New FDA and EMA Oncology Drug Approvals in Q2 2024 Largely Focused on Biologics and Specific Molecular Targets

In Q2 2024, FDA and EMA approved 26 new/expanded indications and 9 new oncology agents, targeting 19 solid tumors and 5 hematologic malignancies. Highlights include 6 NSCLC treatments, 4 tumor-agnostic approvals, and 3 biologics for follicular lymphoma. Key approvals: alectinib, durvalumab, epcoritamab. Safety updates included hepatotoxicity risks and CAR T-cell therapy warnings.

Johnson & Johnson submits BLA to FDA for lung cancer drug

Johnson & Johnson seeks FDA approval for SC amivantamab in NSCLC treatment, showing comparable efficacy to IV form in Phase III trials. The SC version offers a quicker administration, aiming to improve patient and healthcare provider experience.
onclive.com
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Amivantamab Plus Lazertinib Improves PFS Irrespective of EGFR-Mutant NSCLC Patient Risk

Amivantamab-vmjw plus lazertinib significantly improved progression-free survival (PFS) over osimertinib in high-risk EGFR-mutant NSCLC patients, showing a 30% reduced risk of disease progression or death and a 7.1-month PFS improvement. Superior outcomes were noted in patients with TP53 co-mutations, detectable ctDNA, brain, and liver metastases.
lcfamerica.org
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J&J's lung cancer therapy succeeds in head-to-head study with AstraZeneca's Tagrisso

Johnson & Johnson's Rybrevant showed similar effectiveness to AstraZeneca's Tagrisso in treating advanced EGFR mutant NSCLC, with both drugs shrinking or halting tumor growth in about 75% of patients after a year. Rybrevant, approved in 2021 as a second-line treatment, may now also serve as an initial treatment option alongside Tagrisso, offering more effective choices to extend patient lives.
egfrcancer.org
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Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint

Janssen Pharmaceutical announced positive Phase 3 MARIPOSA study results for RYBREVANT® combined with lazertinib, showing improved progression-free survival in EGFR-mutated NSCLC patients compared to osimertinib. The combination's safety profile aligns with previous data, with a trend favoring overall survival. Further OS analyses are planned.
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