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
- -
Rybrevant Plus Chemotherapy May Improve PFS for Relapsed EGFR Lung Cancer
Rybrevant (amivantamab) plus chemotherapy significantly improves progression-free survival in relapsed, advanced EGFR-mutant non-small cell lung cancer. The treatment is approved in Europe and pending FDA approval. It causes infusion reactions initially but is being reformulated as a subcutaneous injection to reduce these reactions. Common side effects include skin and nail changes, which can be managed with early intervention.
FDA Roundup: Oncology Drug Alerts
In September, the FDA approved 9 new treatments for various cancers, including bortezomib for multiple myeloma and mantle cell lymphoma, ribociclib for breast cancer, biosimilar trastuzumab-strf for breast, gastric, and gastroesophageal cancers, and atezolizumab plus hyaluronidase for non-small cell lung, small cell lung, hepatocellular, melanoma, and alveolar soft part sarcoma. Other approvals included amivantamab-vmjw and osimertinib for non-small cell lung cancer, pembrolizumab for malignant pleural mesothelioma, isatuximab-irfc for multiple myeloma, and selpercatinib for thyroid cancer.
Regeneron takes the long-haul approach to oncology, stumbles and all
Regeneron, despite being a latecomer in cancer therapies, aims to leverage its packed pipeline to become a leader in the next wave of oncology treatments. Dr. Israel Lowy, senior vice president of translational and clinical sciences in oncology, highlights the company's focus on combinations like Libtayo and fianlimab, which could rival existing treatments like Opdualag and Keytruda. Regeneron's journey includes pioneering bispecific antibodies and facing early challenges, but with ongoing clinical trials and collaborations, the company seeks to establish itself as a major player in cancer therapy.
Johnson & Johnson (JNJ) Q3 2024 Earnings Call Transcript
Johnson & Johnson reported strong Q3 2024 results with 6.3% operational sales growth, driven by high-innovation and high-growth markets. Key achievements include FDA approvals for Rybrevant and Tremfya, significant sales from Darzalex and Carvykti, and strategic acquisitions like Shockwave and V-Wave. Despite challenges in Asia-Pacific, the company remains confident in its growth trajectory and has increased its 2024 financial guidance.
The OncFive: Top Oncology Articles for the Week of 9/29
FDA approves perioperative nivolumab for resectable NSCLC; locally produced CAR T-cell therapy shows 92% ORR in R/R multiple myeloma; FDA grants priority review to acalabrutinib for treatment-naive mantle cell lymphoma; September 2024 saw key FDA approvals in oncology; recap of September 2024 OncLive On Air episodes.
Related Clinical Trials:
September Roundup of Key FDA Approvals in Oncology
FDA approved bortezomib for multiple myeloma and mantle cell lymphoma, atezolizumab and hyaluronidase-tqjs for subcutaneous use in all IV atezolizumab indications, ribociclib plus an aromatase inhibitor for HR+/HER2- breast cancer, pembrolizumab plus chemo for malignant pleural mesothelioma, amivantamab plus chemo for EGFR+ advanced NSCLC post EGFR inhibition, isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma, osimertinib for locally advanced, unresectable EGFR+ NSCLC after chemoradiation, and selpercatinib for RET fusion+ medullary thyroid cancer.
Related Clinical Trials:
Patient-Centered Discussions Will Be Critical to Navigate Treatment Selection in EGFR+ NSCLC
Isabel Preeshagul, DO, MBS, emphasizes the importance of shared decision-making in selecting optimal treatment for EGFR-mutated NSCLC, highlighting the expanded options from FLAURA2 and MARIPOSA trials. She discusses the need for patient-centered care, considering comorbidities and treatment tolerability, and the complexities of perioperative vs neoadjuvant approaches without head-to-head comparisons.
Related Clinical Trials:
FDA Approvals in Oncology: July-September 2024
The FDA approved 16 oncology therapies in Q3 2024, including first-in-class TCR T-cell therapy afami-cel for synovial cell sarcoma, denileukin diftitox for cutaneous T-cell lymphoma, and axatilimab-csfr for chronic graft-versus-host disease. Vorasidenib was approved for grade 2 astrocytoma or oligodendroglioma, and three EGFR-targeting therapies for non-small cell lung cancer. New formulations of atezolizumab and daratumumab with hyaluronidase were approved, along with expanded indications for durvalumab, isatuximab, and ribociclib. Selpercatinib was approved for pediatric medullary thyroid cancer, and pembrolizumab and dostarlimab-gxly received biomarker-agnostic approvals for malignant pleural mesothelioma and endometrial cancer, respectively.
September 2024 FDA Roundup: Key Decisions Drive Oncology Forward
In September 2024, the FDA approved multiple oncology treatments, including subcutaneous atezolizumab, ribociclib for early breast cancer, isatuximab for multiple myeloma, selpercatinib for medullary thyroid cancer, and osimertinib for advanced NSCLC. Other approvals included OBX-115 for melanoma, FoundationOne CDx and Liquid CDx for prostate cancer, subcutaneous bortezomib, IBI363 for melanoma, 212Pb VMT01 for melanoma, ABD-147 for neuroendocrine carcinoma, certepetide for cholangiocarcinoma, tebapivat for myelodysplastic syndromes, elraglusib for soft tissue sarcoma, VNX-101 for leukemia, P-BCMA-ALLO1 for multiple myeloma, adjuvant ribociclib for breast cancer, pembrolizumab for mesothelioma, ICT01 for leukemia, CF33-hNIS for cholangiocarcinoma, trastuzumab-strf, amivantamab for NSCLC, CD-001, isatuximab for multiple myeloma, EO-3021 for gastric cancer, camrelizumab for HCC, LP-184 for rare pediatric tumors, osimertinib for NSCLC, and selpercatinib for medullary thyroid cancer.
Related Clinical Trials:
Amivantamab Accolades Add Up for NSCLC
Amivantamab (Rybrevant) has received 3 FDA approvals for EGFR-mutated non–small cell lung cancer (NSCLC), including first-line use in EGFR exon 20 insertion mutations, a chemotherapy-free regimen with lazertinib for exon 19 deletions or exon 21 L858R mutations, and with standard chemotherapy for patients with exon 19 deletions or exon 21 L858R mutations post-EGFR TKI treatment. The MARIPOSA trial evaluated amivantamab plus lazertinib versus osimertinib, showing superior progression-free survival.
Drug Development Updates
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