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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rybrevant.com
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RYBREVANT® (amivantamab-vmjw)

Consult your doctor to understand which lung cancer types RYBREVANT® is approved to treat.
targetedonc.com
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Amivantamab and Lazertinib Combo Extends Survival in EGFR-Mutated NSCLC Patients

The MARIPOSA study showed amivantamab-vmjw plus lazertinib significantly improved overall survival over osimertinib in EGFR-mutated NSCLC patients, with median OS improvement expected to exceed 1 year. The combination also showed a median PFS of 23.7 months vs 16.6 months for osimertinib, with an ORR of 86% vs 85%. Safety profiles were consistent, with prophylactic anticoagulants reducing thrombosis risk. Results offer hope for extending life in EGFR-positive lung cancer patients.

FDA Grants Priority Review to Sunvozertinib for EGFR Exon20ins Mutations in NSCLC

Sunvozertinib, an oral EGFR inhibitor, showed promising results in treating NSCLC with EGFR exon20ins mutations, with a best ORR of 53.3% and cORR of 44.9%. The FDA granted it priority review, highlighting its potential as a convenient, safe, and effective treatment option for this patient population.
onclive.com
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Sunvozertinib Under FDA Priority Review for NSCLC With EGFR Exon 20 Mutations

The FDA granted priority review to sunvozertinib (DZD9008) for NSCLC with EGFR exon 20 mutations, based on WU-KONG1 Part B trial results showing a 53.3% ORR. Sunvozertinib offers a promising, convenient treatment option for patients with limited alternatives, despite common TRAEs like diarrhea and anemia.

Subcutaneous options offer convenience for patients and a valuable window for drugmakers

Pharma companies are increasingly adopting subcutaneous injections for drugs, offering convenience and extending patent exclusivity. Examples include Merck's Keytruda and J&J's Tremfya. These options cater to patient preferences, especially for chronic conditions, by minimizing treatment disruptions. Despite challenges in drug delivery and manufacturing, advancements aim to enhance patient care and market competitiveness.
pharmaphorum.com
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J&J gets CHMP nod for Rybrevant in first-line lung cancer

Johnson & Johnson’s Rybrevant nears EU approval for EGFR-positive lung cancer treatment, following EMA’s CHMP recommendation. Proven effective in the PAPILLON study, it significantly reduces disease progression risk. J&J aims to expand Rybrevant’s use, challenging AstraZeneca’s Tagrisso, amidst emerging competitors in the NSCLC treatment landscape.

Rybrevant plus Lazcluze Improve Survival in Lung Cancer

Johnson & Johnson's Phase 3 MARIPOSA study showed rybrevant plus lazcluze significantly improved overall survival in EGFR-mutated NSCLC patients, surpassing osimertinib. The safety profile remained consistent, with results to be presented at a medical meeting and shared with health authorities.
rttnews.com
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JNJ's RYBREVANT, LAZCLUZE Show Survival Gains In Lung Cancer

Johnson & Johnson announced positive Phase 3 MARIPOSA study results for RYBREVANT and LAZCLUZE as first-line therapy for EGFR-mutated NSCLC, showing significant improvement in median overall survival over osimertinib. The combination, already approved in the U.S. and Europe, offers hope for extending life expectancy in advanced NSCLC patients.
yahoo.com
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J&J says cancer drug combination showed survival benefit over Tagrisso

Johnson & Johnson's combination of Rybrevant and Lazcluze showed improved median overall survival over AstraZeneca's Tagrisso in advanced lung cancer patients, potentially changing treatment standards. Despite side effects, the regimen's survival benefit may influence its adoption over Tagrisso.
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