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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

PubMedOral oncology2026-10-14

Prognostic significance and predictors of pathological response following neoadjuvant paclitaxel, carboplatin, and cetuximab therapy in head and neck squamous cell carcinoma.

Suzuki Kei K, Ueki Yushi Y, Ohno Yuki Y, Ohshima Shusuke S et al.

Neoadjuvant chemotherapy using paclitaxel, carboplatin, and cetuximab (PCE-NAC) is used in patients with locally advanced head and neck squamous cell carcinoma (HNSCC); however, predictors of survival outcome remain unclear. This study aimed to evaluate the prognostic value of the pathological response to PCE-NAC and identify clinical factors associated with a favorable pathological response. We retrospectively reviewed 59 patients with HNSCC who underwent PCE-NAC followed by surgery at our institution. Pathological response was assessed according to the General Rules for Clinical and Pathological Studies on Head and Neck Cancer in Japan and categorized as favorable pathological response (≥ Grade 2, less than one-third of cancer cells are viable). Recurrence-free survival (RFS) was analyzed using Kaplan-Meier and Cox proportional hazard analyses. Logistic regression analysis was performed to identify the predictors of favorable pathological response. A favorable pathological response (≥ Grade 2) was obtained in 42.4 % of patients, which was significantly associated with better 2-year RFS (80.1 % vs. 62.7 %, p = 0.032). In contrast, pathological complete response and radiological response (complete or partial response) were not significantly associated with prognosis. Multivariable logistic regression analysis determined that younger age and female sex were associated with a favorable pathological response. Pathological response beyond pCR may provide clinically meaningful information on treatment efficacy following PCE-NAC. Younger age and female sex were associated with a favorable pathological response, suggesting their potential relevance to treatment response.

PMID 42874320
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PubMedClinical colorectal cancer2026-10-11

EGFR Targeting With Afatinib and Cetuximab Versus Cetuximab Alone in Chemorefractory Wild-type RAS Metastatic Colorectal Cancer: A Randomized Phase II Study With Circulating Tumor Cell Analysis.

Simmet Victor V, Lièvre Astrid A, Samalin Emmanuelle E, Senellart Hélène H et al.

This phase II randomized trial evaluated the efficacy and safety of the combination of cetuximab and afatinib in chemorefractory metastatic colorectal cancer (mCRC). We conducted a multicentre, open-label, randomized 2/1 noncomparative clinical trial in 75 patients with wild type (wt) RAS mCRC after chemotherapy failure. Patients (n = 51) received oral afatinib (40 mg/d) in combination with intravenous cetuximab (500 mg/m2 every 2 weeks) or cetuximab alone (n = 24) as an internal control arm. Crossover to afatinib was allowed after disease progression. The primary endpoint was the 6-month nonprogression rate with a minimal success rate of 30%. The prognostic value of circulating tumor cells (CTCs) was assessed in an ancillary analysis. In the combination arm, 9 patients (18%; 95% confidence interval [CI], 8-31), were progression-free at 6 months (primary endpoint not met). The objective response rate (ORR) was 26% (95% CI, 14-40). Median PFS and overall survival (OS) were 4.1 months (95% CI, 2.7-5.4) and 13.6 months (95% CI, 7.7-18.5) respectively. Thirty-seven patients (76%) in the combination arm and 16 patients (64%) in the control arm reported at least one severe (grade ≥ 3) toxicity. Two patients in the combination arm had grade 5 toxicity (sudden death and hypoglycemia). High baseline CTC levels and their decrease at day 14 were correlated to OS and ORR. CTC levels at day 14 were correlated to PFS. The combination of afatinib and cetuximab was ineffective in treating chemorefractory wtRAS mCRC, and associated with high toxicity.

PMID 42859101
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PubMedVeterinary journal (London, England : 1997)2026-10-09

Development of a feline Cetuximab with therapeutic potential against feline oral squamous cell carcinoma.

Altamura Gennaro G, Finizio Arianna A, Napolano Alessandra A, Capasso Chiara C et al.

Cetuximab is a chimeric murine-human anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) employed in the therapy of head and neck squamous cell carcinoma (HNSCC). Feline oral squamous cell carcinoma (FOSCC), the counterpart of HNSCC, is unresponsive to standard treatments and often lethal for affected cats. As EGFR is highly conserved between humans and cats, our research group attempted to test anti-cancer properties of Cetuximab in EGFR-positive FOSCC preclinical models, obtaining encouraging results in recent work. With the present study, we aimed at generating a "felinized" version of Cetuximab suitable for conducting future clinical trials in cat. A chimeric murine-feline IgG composed of variable regions of clinical Cetuximab fused with feline κ and γ constant regions was successfully generated with molecular biology methods. Immunofluorescence assays showed that the purified feline Cetuximab (f-Cetuximab) efficiently bound to human target in transfected cells (J-EGFR) as well as cancer cells endogenously overexpressing EGFR (MDA-MB-231, CAL-27); additionally, flow cytometry demonstrated that the engineered mAb bound feline EGFR in FOSCC cell lines SCCF1/2/3. Most importantly, f-Cetuximab impaired EGFR activity and inhibited cell proliferation in feline (SCCF1/3) and human (CAL-27) oral SCC cell lines. Moreover, LDH-based assays conducted by co-culturing SCCF3 cells and feline peripheral blood mononuclear cells revealed that f-Cetuximab elicited antibody-dependent cell-mediated cytotoxicity, which might be pivotal for therapeutic efficacy of this mAb in vivo. In conclusion, with this study we established a highly specific and effective candidate for an innovative mAb-based therapeutic approach against FOSCC, paving the way for the introduction of molecular targeted therapy in veterinary oncology.

PMID 42854821
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PubMedInternational journal of clinical oncology2026-10-09

Association between tumor volume reduction and treatment outcomes in nasopharyngeal carcinoma treated with PCE-based induction chemotherapy and concurrent chemoradiotherapy.

Guo Ya Y, Saito Satoshi S, Makita Kenji K, Enokida Tomohiro T et al.

This study aimed to evaluate the association between total tumor volume reduction rate (VRR) and treatment outcomes in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC) treated with paclitaxel, carboplatin, and cetuximab (PCE)-based induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT). Patients with LA-NPC who were planned to undergo IC-PCE followed by CCRT between September 2017 and December 2024 were included. Overall survival (OS) and progression-free survival (PFS) were calculated, and factors associated with PFS were evaluated. VRR was dichotomized based on a cutoff value derived from receiver operating characteristic curve analysis. In total, 43 consecutive patients with LA-NPC (median age, 56 years) were included. The median follow-up time was 48 months (Interquartile Range, 34-69). The 3-year OS and PFS were 95.3% and 76.1%, respectively. A total of 12 PFS events were observed, including locoregional recurrence (n = 3), distant metastasis (n = 6), both (n = 1), and death (n = 2). In multivariable analysis adjusted for cStage (Union for International Cancer Control 9th edition), a high VRR (cutoff value, 48.6%) was identified as a significant factor associated with improved PFS (hazard ratio, 0.21; 95% confidence interval, 0.06-0.70; p = 0.01). VRR was associated with PFS, suggesting that tumor shrinkage following IC-PCE may serve as a prognostic marker.

PMID 42853545
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PubMedmAbs2026-10-08

Tangential flow filtration as a novel approach for fluorescent tracer purification and production up-scaling: cetuximab-800CW and ustekinumab-800CW as a proof-of-concept.

Huizinga Henrik K HK, van Dijken Rosalie J RJ, Gareb Bahez B, Dekkers Bart G J BGJ et al.

Fluorescence molecular imaging using fluorescently labeled antibodies enables identification of target cells and provides pharmacological insight into local drug distribution. The current GMP manufacturing method of tracers using PD-10 columns is subject to methodological constraints when handling low antibody concentrations, large quantities, or incompatible antibodies. This study presents Tangential Flow Filtration (TFF) as a novel and scalable approach to manufacture clinical-grade fluorescent tracers and demonstrates its applicability using cetuximab-800CW and ustekinumab-800CW. TFF system settings were optimized for purification of cetuximab-800CW and ustekinumab-800CW with labeling parameters and quality control similar to tracer production with PD-10 columns. Cetuximab-800CW production was successfully transitioned from PD-10 to TFF. QC-data after manufacturing with TFF (n = 7) or PD-10 (n = 21) were compared at release and up to 24 months of storage at 2-8°C. This revealed TFF purification to be more efficient and robust, with label efficiencies of 93.5 ± 2.3% with TFF compared to 68.3 ± 6.9% with PD-10, and 0.0 ± 0.1% unconjugated dye with TFF compared to 0.5 ± 0.3% with PD-10. Stability data were comparable for both methods. TFF manufacturing yielded clinical-grade cetuximab-800CW batches stable for at least 24 months. Concentrations ranged from 0.99-1.08 mg/mL and target binding affinity from 65-98%. Detected free dye and aggregates remained well below 3.0%. Moreover, ustekinumab-800CW was successfully manufactured using TFF after PD-10 manufacturing failed due to particle formation. Ustekinumab-800CW was stable up to 24 months at 2-8°C. Together, this demonstrates the feasibility of using TFF for clinical-grade fluorescent tracer manufacturing under GMP conditions.

PMID 42850075
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PubMedAnti-cancer drugs2026-10-06

Pathologic complete response after first-line tislelizumab, cetuximab, and dabrafenib in microsatellite-stable BRAF V600E-mutant metastatic colorectal cancer: a case report.

Li Rong R, Lin Yanping Y, Guo Jiangyan J, Qian Junyi J et al.

BRAF V600E-mutant metastatic colorectal cancer (mCRC) is characterized by aggressive disease behavior and limited responsiveness to conventional systemic therapy. Although BRAF/EGFR-targeted therapies have improved clinical outcomes, durable complete remission remains uncommon, particularly in microsatellite-stable (MSS) disease. We report the case of a 26-year-old woman with MSS, BRAF V600E-mutant sigmoid colon adenocarcinoma and synchronous liver and omental metastases (cT4aN2M1c, stage IVC). Pretreatment biopsy demonstrated high programmed death-ligand 1 (PD-L1) expression (combined positive score = 20) and a high density of intratumoral CD8+ T cells (350 cells/mm2). Because the patient declined cytotoxic chemotherapy, first-line treatment consisted of tislelizumab combined with cetuximab and dabrafenib. After approximately 4 months of systemic therapy, radiological assessment showed a partial response, accompanied by normalization of serum marker levels, enabling conversion surgery. Histopathological examination confirmed a pathological complete response in the primary tumor and all resected metastatic lesions. A personalized tumor-informed circulating tumor DNA assay performed 3 months after surgery was negative. At the latest follow-up (35 months after treatment initiation), the patient remained free of clinical and radiological evidence of disease recurrence. This case highlights the possibility that selected patients with MSS, BRAF V600E-mutant mCRC may achieve durable remission with combined programmed cell death protein 1 blockade and dual-targeted therapy. The observed association between high intratumoral CD8+ T-cell infiltration, elevated PD-L1 expression, and favorable treatment response should be considered hypothesis-generating and requires validation in prospective biomarker-driven studies.

PMID 42837492
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