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cetuximab (Lupitux / Cetuxa / ENZ124)

✓ Approved

Lupin Limited · EGFR · Monoclonal Antibodies

What is cetuximab?

cetuximab is a monoclonal antibodies developed by Lupin Limited. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesLupitux, Cetuxa, ENZ124
CompanyLupin Limited
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetEGFR
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Lupin Limited

Mechanism of Action

Molecular Targets

cetuximab acts on 1 molecular target:

EGFRepidermal growth factor receptor (ERBB1, NNCIS)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

cetuximab is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Head and neck cancer metastatic✓ Approved

Related Research Articles

PubMedAnalytical chemistry2026-11-11

Probing Molecular Binding Mechanisms between a Therapeutic Antibody and an Antigen Mimotope Peptide In Situ in Real Time at a Buried Interface.

Wu Guangyao G, Qin Xiaoxue X, Fathi Fatemeh F, Chen Xuhong X et al.

Bioanalytical platforms, such as biosensors and biochips, are widely used for detecting biomolecules including antibodies. Determining the conformation and orientation of antibodies captured by surface-immobilized recognition elements is essential for designing biosensors and biochips with improved performance. However, obtaining such structural information remains challenging because antibodies are located at buried solid/liquid interfaces that are difficult to characterize. Here, we investigated the binding interaction between Herceptin (trastuzumab), a therapeutic monoclonal antibody, and CH19, a HER2 mimotope peptide immobilized at a buried solid/liquid interface. Sum frequency generation (SFG) vibrational spectroscopy revealed specific binding of Herceptin to the surface-immobilized CH19 peptide, whereas no detectable interaction was observed for the non-target antibodies Cetuximab and Rituximab. By integrating SFG measurements with molecular dynamics (MD) simulations and one-exciton Hamiltonian spectral calculations, we determined the interfacial molecular structure of Herceptin and found that the antibody adopts a lying-down orientation on the CH19-functionalized surface. These combined experimental and computational results demonstrate that CH19-Herceptin recognition at the interface differs fundamentally from the corresponding interaction in solution, highlighting the unique influence of interfacial environment on antibody-antigen recognition. Our results support a surface-enabled multivalent binding model, in which multiple immobilized CH19 peptides interact with broader regions of Herceptin and generate a contact pattern distinct from that in solution. These results demonstrate that the combined SFG, MD, and spectral-calculation approach can determine the molecular structure of a full-length antibody at a buried interface, offering valuable insights for the rational design of biosensors, biochips, and other surface-based biorecognition analytical technologies.

PMID 43010483
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PubMedJournal of cancer policy2026-11-10

Common targets, unfunded therapies: regulatory mapping and cost-utility of precision oncology for metastatic colorectal cancer in Brazil's public health system.

Tustumi Francisco F, Maegawa Felipe Antonio Boff FAB, de Almeida Leite Rodrigo Moisés RM, Seid Victor Edmond VE et al.

Molecular targets are common in metastatic colorectal cancer, yet Brazil's Unified Health System (SUS) does not fund any biomarker-matched therapy. Where each pathway is interrupted-evidence, regulatory indication, incorporation, testing, or price-and what would overcome each barrier remain unclear. We quantified actionable biomarker prevalence in TCGA-COADREAD (n=459), mapped each biomarker-therapy pathway across the Brazilian access chain using primary regulatory sources (2025 national protocol, CONITEC, ANVISA, SIGTAP), and developed partitioned-survival cost-utility models (SUS perspective, lifetime horizon, 5% annual discounting), conditional on biomarker-positive patients, evaluating first-line pembrolizumab (KEYNOTE-177), first-line cetuximab in left-sided RAS wild-type disease (CRYSTAL), and first-line encorafenib plus cetuximab plus mFOLFOX6 (BREAKWATER, interim survival), with second-line BEACON examined as a scenario. Drugs were costed at regulated government-purchase ceiling prices; results were assessed against Brazil's 2022 reference threshold of R$40,000/QALY, with the threefold value (R$120,000/QALY) as a scenario for specific circumstances. In the mixed-stage TCGA-COADREAD cohort - characterizing theoretical molecular opportunity - RAS wild-type status was observed in 51.4%, MSI-high in 16.6%, and BRAF V600E in 9.8%, yet every matched pathway was interrupted at or before national incorporation. Incremental cost-effectiveness ratios were R$314,000/QALY for pembrolizumab, R$761,000/QALY for cetuximab (exploratory), and R$836,000/QALY for first-line BRAF-targeted therapy. No non-negative encorafenib price alone brought the BRAF regimen below either threshold; achieving cost-effectiveness would require joint reductions of 75-84% in encorafenib and cetuximab prices. Precision oncology in SUS is constrained not by target scarcity, but by pathway-specific barriers to incorporation and affordability. Different pathways require different policy responses: negotiated pricing for pembrolizumab, substantial class-level price reductions for anti-EGFR antibodies, and regimen-level negotiation covering both targeted agents in the BRAF combination. Identifying each pathway's barrier turns a generic affordability problem into a concrete target for health technology assessment and pricing decisions in middle-income health systems.

PMID 43009051
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PubMedInternational journal of clinical oncology2026-11-10

Risk factors for pneumonitis development in patients with platinum-refractory head and neck cancer treated with salvage-line chemotherapy after nivolumab failure.

Nishimura Ari A, Watanabe Takane T, Oka Hiroki H, Nagashima Kengo K et al.

Immune checkpoint inhibitors (ICIs) have improved the survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN), thus potentially enhancing the efficacy of subsequent salvage-line chemotherapy (SLC). However, ICIs can cause immune-related adverse events such as pneumonitis. Because SLC often includes potentially pneumotoxic agents, the risk of pneumonitis following ICI treatment is a clinical concern. Therefore, this study aimed to identify clinical risk factors for pneumonitis during SLC. This retrospective analysis included 244 patients from a previously published cohort (N = 480) who underwent SLC after platinum-based chemotherapy and nivolumab failure. Baseline characteristics and SLC regimens of patients with and without pneumonitis development were compared. Candidate risk factors included age 65 years or older, smoking history, prior cetuximab exposure, SLC regimen, renal dysfunction, baseline lung disease, and nivolumab-induced pneumonitis history. Pneumonitis occurred in 12 (4.9%) patients during SLC (grade 1, n = 3; grade 2, n = 6; grade 3, n = 3). Treatment regimens included paclitaxel plus cetuximab (n = 3), taxane alone (n = 6), and S-1 (n = 3). A clear relationship between the treatment regimen and pneumonitis severity was not observed. In the univariate analysis, age 65 years or older and smoking history were significantly associated with pneumonitis, while a history of nivolumab-related pneumonitis was strongly associated with pneumonitis. Prior nivolumab-related pneumonitis was strongly associated with pneumonitis development during subsequent SLC and may be a clinically relevant risk factor for pulmonary toxicity in patients who received ICIs.

PMID 43007584
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PubMedFrontiers in pharmacology2026-11-08

Cost-effectiveness analysis of cetuximab for the treatment of head and neck cancers in India.

Gupta Nidhi N, Dixit Jyoti J, Jyani Gaurav G, Prinja Shankar S

Head and neck cancers (HNC) comprise 5% of all malignancies worldwide. Cetuximab is the first targeted therapy to demonstrate a significant survival benefit in patients with locally advanced HNC (LAHNC) and recurrent or metastatic HNC (R/MHNC). In view of this, we undertook this economic evaluation to ascertain the costs and health benefits associated with (i) the use of RT + CTX over RT alone for LAHNC patients who are ineligible for cisplatin-based chemoradiotherapy and (ii) CT + CTX over CT alone for R/MHNC patients from the perspective of Indian healthcare system. A Markov model was constructed to assess the lifetime costs and health outcomes using cetuximab in combination with radiotherapy (RT + CTX) for treatment of cisplatin-ineligible LAHNC (Analysis I), and cetuximab in combination with platinum-based chemotherapy (CT + CTX) for treatment of R/MHNC patients in India (Analysis II). Using an abridged societal perspective lifetime costs and quality adjusted life years (QALYs) were evaluated, discounting future costs and consequences at 3% annually. For both the analyses, costs of original as well as biosimilar cetuximab were evaluated. The cost-effectiveness was assessed in terms of incremental cost effectiveness ratio (ICER) which was compared against a threshold of 1-time per capita gross domestic product (GDP) for India in 2024-25 (₹ 247,045; US$ 2,697). Adding biosimilar cetuximab to radiotherapy for cisplatin-ineligible LAHNC patients resulted in 2.73 (95% CI: 2.11-3.30) QALYs, while adding biosimilar cetuximab to platinum-based chemotherapy for R/MHNC resulted in 0.78 (95% CI: 0.61-0.96) QALYs over the modelled lifetime horizon. The incremental cost per QALY gained was found to be ₹ 501,320 with use of RT + CTX and ₹ 15,023,037 with use of CT + CTX. At the currently recommended willingness to pay (WTP) threshold, treatment with cetuximab is not a cost-effective treatment option for patients with LAHNC and R/MHNC patients respectively in India. A 50% reduction in the price of biosimilar would make it a cost-effective option for treatment of LAHNC in India. Strategic purchasing of biosimilar cetuximab at reduced price can provide good value for money for treatment of patients with LAHNC.

PMID 42996330
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PubMedbioRxiv : the preprint server for biology2026-11-08

Fast receptor-antigen dissociation kinetics promote CAR-T cell tumor infiltration, functional fitness, and antitumor efficacy in solid tumors.

Mao Rui R, Shi Huidong H, Hussein Mohamed S MS, Karia Bela B et al.

CAR-T cells have shown limited efficacy against solid tumors, where they face two major challenges: restricted tumor infiltration and sustained intensive engagement that drive them to exhaustion. Conventional CAR design has largely emphasized high-affinity interactions with slow dissociation, further limiting tumor infiltration and exacerbating exhaustion and dysfunction. We hypothesize that most current CARs are kinetically over-stabilized for solid tumors and that a fast-on/fast-off, " cheek-kiss " mode of engagement permits transient CAR-antigen disengagement, thereby facilitating tumor infiltration and preserving CAR-T cell fitness in tumor mass. We identified two monoclonal antibodies targeting the same epitope of epidermal growth factor receptor with comparable k on but distinct k off rates: cetuximab (Cet) and its humanized derivative H1. CAR-T cells incorporating these binders were evaluated in vitro and in vivo . Large, established human tumor xenografts were treated with low-dose CAR-T cells in NSG mice to model conditions of limited T cell availability and sustained tumor antigen exposure. Cet and H1 exhibited comparable k on but markedly different k off rates, with H1 displaying fast-off kinetics with approximately 18-fold shorter binding dwell time. As CARs, H1 showed reduced antigen occupancy and less stable tumor-T cell engagement than Cet. Despite comparable in vitro cytotoxicity, H1 CAR-T cells accumulated more efficiently following tumor stimulation. At high doses, both CAR-T cell products eradicated established tumors. Under low-dose conditions, however, H1 CAR-T cells exhibited superior expansion, persistence, tumor infiltration, and antitumor efficacy, whereas Cet CAR-T cells showed limited expansion and only transient tumor control. Cet CAR-T cells progressively downregulated surface CAR expression, increased PD-1 expression, and exhibited reduced tumor infiltration and impaired functional recovery. In contrast, H1 CAR-T cells preserved surface CAR expression, exhibited greater tumor infiltration, maintained a less exhausted, more central memory-like phenotype, and retained effector function. Fast-on/fast-off binding kinetics enhance CAR-T tumor infiltration, expansion, persistence, and functional fitness, resulting in improved control of established solid tumors. The data provides a rationale for shifting CAR design from affinity optimization toward kinetic optimization to improve the efficacy and safety of CAR-T therapy for solid tumors. CAR design has largely focused on antigen-binding affinity, whereas the contribution of binding kinetics, particularly the dissociation rate, to CAR-T cell function, expansion, persistence, tumor infiltration, and antitumor efficacy remains poorly defined. In this study, we found that, compared with slow-off binding, fast-off kinetics enhance CAR-T cell tumor infiltration, expansion, persistence, and functional fitness in tumor-bearing mice, revealing previously underappreciated effects of antigen-binding kinetics on CAR-T cell tumor infiltration and performance in solid tumors. This study provides a rationale for incorporating antigen-binding kinetics into CAR design and optimization. The TCR-inspired fast-on/fast-off antigen engagement may help CAR T cells maintain fitness during sustained antigen exposure and thereby improve their infiltration, persistence, and antitumor activity in solid tumors.

PMID 42999450
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PubMedMedicine2026-11-06

Comparative efficacy and safety of second- and later-line BRAF-targeted regimens in BRAF V600E-mutant metastatic colorectal cancer: A systematic review and network meta-analysis.

Arsalan Muhammad M, Sawaira F N U FNU, Hassan Irtaza I, Hassan Taimoor T et al.

BRAF V600E mutations occur in approximately 8 to 12% of metastatic colorectal cancer (mCRC) cases and define an aggressive phenotype with poor prognosis. While the BEACON CRC trial established encorafenib-based combinations as effective second-line options, direct head-to-head comparisons among available BRAF-targeted regimens are lacking. This network meta-analysis (NMA) compared the relative efficacy and safety of second- and later-line BRAF-targeted regimens in BRAF V600E-mutant mCRC. PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov were searched from inception through January 2026. Eligible studies enrolled adult patients with BRAF V600E-mutant mCRC receiving second- or later-line BRAF-targeted therapy and reported time-to-event survival outcomes. A frequentist NMA was conducted under a random-effects model using the netmeta package in R. Hazard ratios (HRs) with 95% confidence intervals (CIs) were pooled for progression-free survival (PFS) and overall survival (OS). Where HRs were unavailable, individual patient data were reconstructed from Kaplan-Meier curves using the Guyot method. Treatment ranking used P-scores, with irinotecan plus cetuximab as the reference comparator. Four trials enrolling 922 patients across 9 treatment arms were included. All 4 experimental regimens demonstrated significant PFS benefit over irinotecan plus cetuximab. Encorafenib plus cetuximab plus alpelisib ranked highest for PFS (HR 0.33, 95% CI 0.15-0.71; P-score 0.789), followed by encorafenib plus binimetinib plus cetuximab (EBC; HR 0.38, 95% CI 0.29-0.49), encorafenib plus cetuximab (EC; HR 0.40, 95% CI 0.31-0.50), and vemurafenib plus irinotecan plus cetuximab (HR 0.50, 95% CI 0.32-0.77). For OS, only EBC (HR 0.52, 95% CI 0.39-0.69) and EC (HR 0.59, 95% CI 0.46-0.76) achieved statistically significant benefits. No significant difference was detected between EBC and EC on either endpoint. No between-study heterogeneity was detected (I2 = 0%). In the exploratory safety network, encorafenib plus cetuximab was the only encorafenib-based regimen associated with significantly fewer grade ≥ 3 adverse events than irinotecan plus cetuximab (odds ratio 0.67, 95% CI 0.47-0.96). These findings position encorafenib-based therapy, and encorafenib plus cetuximab in particular, as the reference standard for previously treated BRAF V600E-mutant mCRC, while underscoring that the incremental value of more intensive regimens must be weighed against tolerability and confirmed in adequately powered trials.

PMID 42994867
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