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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theglobeandmail.com
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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.
marketscreener.com
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J&J: positive CHMP opinion for Lazcluze in lung cancer

J&J's Janssen-Cilag receives CHMP recommendation for Lazcluze + Rybrevant in advanced NSCLC with EGFR mutations, based on a phase 3 study showing a 30% reduction in progression or death risk compared to osimertinib.

CHMP Recommends Approval Of Lazcluze + Rybrevant In EU For EGFR-mutated Advanced NSCLC

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Medicines Agency's CHMP recommended approval of Lazcluze with Rybrevant for EGFR-mutated advanced NSCLC. The CHMP also recommended a Type II indication extension for amivantamab in the same combination. These recommendations are supported by the Phase III MARIPOSA study, which showed a 30% reduction in disease progression or death compared to Tagrisso, with a median progression-free survival of 23.7 months versus 16.6 months for Tagrisso.
marketscreener.com
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CHMP recommends RYBREVANT in combination with LAZCLUZE for the first-line treatment

Janssen-Cilag International NV announced CHMP's recommendation for LAZCLUZE (lazertinib) and RYBREVANT (amivantamab) for first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. The combination could establish a new standard of care, potentially delaying disease progression and improving outcomes.
koreabiomed.com
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European regulator endorses approving Leclaza combo therapy to treat NSCLC

EMA's CHMP recommended approval of Leclaza (lazertinib) and Rybrevant (amivantamab) for first-line NSCLC treatment, pending EMA decision by late 2024 or early 2025. The combination showed longer progression-free survival but higher adverse events.
ema.europa.eu
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14

EMA's CHMP recommended 8 new medicines for approval, including Augtyro, Gohibic, and Lazcluze, and 4 biosimilars. Extensions of indication were recommended for 11 existing medicines, while marketing authorisations were refused for Cinainu and Kizfizo. CHMP also recommended Leqembi for Alzheimer's patients with specific genetic profiles and updated safety advice for Mysimba. Applications for Izelvay and Inaqovi were withdrawn.
straitstimes.com
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J&J says drug combo contains lung cancer from spreading for longer

Johnson & Johnson announced its combination drug, Rybrevant and lazertinib, extends progression-free survival in non small-cell lung cancer patients with a specific EGFR mutation. Approved in 2021 for a small NSCLC subset, J&J is testing this therapy against Tagrisso, aiming for first-line treatment status.
ajmc.com
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Sunvozertinib NDA Submitted to FDA for NSCLC

FDA NDA submitted for sunvozertinib (DZD9008; Dizal) in EGFR exon 20 insertion mutation–positive advanced NSCLC, post-platinum chemotherapy. Phase 2 WU-KONG1 trial data show 300 mg dose achieved 53.3% best ORR and 44.9% confirmed ORR. Median DOR not reached, with 9-month DOR rate at 57%. Safety consistent with prior studies; 6.3% discontinued treatment.
mugglehead.com
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South Korea's Yuhan has 690% profit spike on U.S. lung cancer drug sales

Yuhan Corp's Q3 financial success attributed to US sales of lung cancer drug Leclaza, leading to a 690% operational profit increase. Developed with Johnson & Johnson, Leclaza combined with Rybrevant showed 30% better disease progression reduction in NSCLC patients than AstraZeneca's Tagrisso. Expected to generate $738M annually, it's the first chemotherapy-free, multitargeted regimen approved for EGFR-mutated NSCLC.
pmlive.com
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J&J's Darzalex regimen approved by EC for newly diagnosed multiple myeloma

J&J's subcutaneous Darzalex approved by EC for NDMM in combination with VRd for ASCT-eligible patients, reducing disease progression risk by 58%.
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