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
-
cancernetwork.com
·

FDA Grants Priority Review to Sunvozertinib for EGFR exon20ins NSCLC

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

J&J says its lung cancer drug combination keeps people alive longer

Johnson & Johnson's lung cancer drugs, Rybrevant and Lazcluze, showed significant survival improvement over AstraZeneca's Tagrisso in trials, potentially extending life by at least a year. Despite more side effects and the need for regular infusions, J&J sees this as a game-changer in treating EGFR-mutated non-small cell lung cancer, with projected annual sales exceeding $5 billion.
stocktitan.net
·

J&J's RYBREVANT Lung Cancer Treatment Shows Significant Improvement in Overall Survival for EGFR-Mutated NSCLC Patients

Johnson & Johnson announced that RYBREVANT® plus LAZCLUZE™ significantly improves overall survival in EGFR-mutated NSCLC patients, exceeding one year over current standard care. This chemotherapy-free regimen marks a breakthrough in first-line treatment, offering hope for extended life expectancy and better outcomes.
markets.ft.com
·

Company Announcement - Markets data

Johnson & Johnson announced that RYBREVANT® plus LAZCLUZE™ significantly improved overall survival in EGFR-mutated NSCLC patients, exceeding one year over the current standard. This chemotherapy-free regimen marks a pivotal advancement in first-line treatment, offering hope for extended life expectancy.
finance.yahoo.com
·

Subcutaneous options offer convenience for patients

Pharma companies are increasingly adopting subcutaneous injections for their convenience and potential to extend drug exclusivity. Examples include Merck's Keytruda and J&J's Tremfya, aiming for IV-free treatments. Challenges like drug delivery and manufacturing exist, but overcoming them can offer significant benefits, including patient preference for less disruptive treatment options.
finance.yahoo.com
·

Pharma Stock Roundup: PFE Ends Hemophilia Deal With SGMO & More

Novartis' OAV101 IT shows promise for SMA; Sangamo regains rights to hemophilia A therapy after Pfizer ends collaboration. J&J's Rybrevant-Lazcluze combo approved for NSCLC in EU. Pharma stocks see mixed performance.
pharmaphorum.com
·

Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

FDA approves AstraZeneca’s Tagrisso with chemotherapy for EGFR-positive NSCLC, reducing disease progression risk by 38%. Study shows 9-month longer progression-free survival. Approval may boost Tagrisso sales, pending overall survival data. Tagrisso is key for EGFR-mutated lung cancer, especially in advanced cases. Faces competition from J&J’s Rybrevant.
targetedonc.com
·

FDA's December 2024 Oncology Approvals and Designations

In December 2024, FDA approved several treatments including zenocutuzumab for NRG1+ NSCLC and pancreatic cancer, cosibelimab for CSCC, and combinations for BRAF V600E+ mCRC. Fast track and breakthrough designations were granted for treatments in MDS, cervical cancer, NSCLC, and SCLC. Priority reviews were given for taletrectinib in ROS1+ NSCLC and remestemcel-L for pediatric acute GVHD.
finance.yahoo.com
·

The Zacks Analyst Blog: Eli Lilly, J&J, AbbVie, AstraZeneca and Pfizer

The drug and biotech industry faced challenges due to political appointments, sales disappointments, and pipeline setbacks but is expected to recover by 2025. Innovation in rare diseases, oncology, and neuroscience, along with strong M&A activity, are key growth drivers. Despite headwinds like patent cliffs and regulatory risks, companies like Eli Lilly, J&J, AbbVie, AstraZeneca, and Pfizer remain strong investment choices due to their robust revenue streams and continuous R&D investments.
oncnursingnews.com
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Evaluating Targeted Therapies: MARIPOSA Trial Aids APPs in Treating EGFR+ NSCLC

Beth Sandy discussed targeted therapies for EGFR-mutated NSCLC, highlighting the MARIPOSA trial's findings. Amivantamab plus lazertinib showed improved PFS over osimertinib, with notable benefits in brain metastasis cases. Adverse events included VTE, with prophylactic anticoagulation recommended. The combination therapy also showed promising OS and intracranial PFS.
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