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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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.
finance.yahoo.com
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FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC

FDA issued a CRL to J&J's BLA for SC Rybrevant for EGFR-mutated NSCLC, unrelated to product safety or efficacy. Rybrevant, approved as IV therapy, seeks SC approval based on phase III PALOMA-3 data. J&J shares fell 8.3% YTD. Rybrevant also gained approvals for NSCLC treatments in combination with Lazcluze and chemotherapy.
drugtopics.com
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New Drug Review: FDA Approves Lazertinib Combination Therapy for Non–Small Cell Lung Cancer

In August 2024, the FDA approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The MARIPOSA trial showed significant improvement in progression-free survival (PFS) with the combination therapy compared to osimertinib monotherapy, with a 30% reduction in disease progression or death. Common adverse reactions included rash, skin toxicity, and venous thromboembolism (VTE). Recommended dosing is 240 mg lazertinib orally with intravenous amivantamab.
cancernetwork.com
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Assessing 2024 Oncology Advances and Looking Ahead

2024 saw transformative advances in oncology, including improved liquid biopsy assays, AI-driven diagnostics, and expanded use of CDK4/6 inhibitors, antibody-drug conjugates, and immunotherapies. Notable approvals included ribociclib for high-risk breast cancer, T-DXd for HER2-low breast and gastric cancers, and tisotumab vedotin-tftv for cervical cancer. Molecular therapies like lazertinib and amivantamab-vmjw for NSCLC, and selpercatinib for medullary thyroid cancer, also advanced. Lifestyle interventions and metabolic therapies showed potential in improving quality of life and anticancer effects.
onclive.com
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Osimertinib Is Most Impactful Addition to 2024 NSCLC NCCN Guidelines and Durvalumab

NCCN guidelines now recommend osimertinib for unresectable NSCLC with EGFR mutations and durvalumab for LS-SCLC, reflecting significant PFS and OS benefits from ADRIATIC and LAURA studies. These updates influence treatment discussions with patients, emphasizing upfront molecular testing and potential systemic therapy post-chemoradiation.
koreabiomed.com
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Homegrown preoperative lung cancer drug Leclaza lowers cancer stages in 55% of patients

Nine weeks of upfront treatment with the anticancer drug Leclaza can lower the stage of inoperable lung cancer patients with EGFR gene mutations, making them eligible for surgery. The study, presented at KATRD 2024, showed 55.8% partial remissions and 97.1% concordance in EGFR gene subtypes, with 77.3% sensitivity for stage I NSCLC diagnosis via lung lavage fluid biopsy.
ascopost.com
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Amivantamab-vmjw Plus Lazertinib Improves Long-Term Outcomes in EGFR-Mutant Advanced NSCLC

Amivantamab-vmjw combined with lazertinib shows superior efficacy over osimertinib alone for EGFR-mutant advanced NSCLC, with 3-year intracranial progression-free survival rates of 38% vs 18%. The MARIPOSA study highlights the combination's improved long-term outcomes, with ongoing research aiming to optimize treatment strategies and minimize toxicity.
medpagetoday.com
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Treatment of Oligometastatic EGFR-Mutant Lung Cancer

EGFR TKIs are effective for EGFR-mutant NSCLC, but patients may still have oligometastatic disease. Local therapy, like radiation, can extend time on systemic therapy and improve PFS and OS. Trials show benefit, but evolving treatments raise questions about radiotherapy's role.
theglobeandmail.com
·

Non-small Cell Lung Cancer Treatment Market 2032: Clinical Trials, Medication, Prevalence

The non-small cell lung cancer market is driven by increasing NSCLC cases, uptake of immune checkpoint inhibitors, emerging premium therapies, and awareness of mutations. DelveInsight's report covers current treatment practices, emerging drugs, market share, and forecasted market size from 2019 to 2032 in 7MM. Key companies and therapies include EMD Serono, Merck, AstraZeneca, Bristol-Myers Squibb, and therapies like M1774, C-TIL051, and Osimertinib. FDA approvals for Opdivo and Tagrisso in 2024 highlight advancements in treatment.
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