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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

Mechanism of Action

Molecular Targets

cetuximab acts on 1 molecular target:

EGFRepidermal growth factor receptor (ERBB1, NNCIS)
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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

PubMedCancer letters2026-05-24

EGFR S442 ectodomain mutation confers cetuximab resistance that can be overcome by ERBB2 blockade with trastuzumab-deruxtecan.

Harmych Sarah J SJ, Joshi Neeraj N, Tanaka Hidenori H, Bogatcheva Galina G et al.

Epidermal growth factor receptor (EGFR) is an oncogenic driver in multiple cancers and a therapeutic target of tyrosine kinase inhibitors and neutralizing monoclonal antibodies. However, resistance to EGFR-targeted therapies, particularly the anti-EGFR antibody cetuximab, remains a clinical challenge in colorectal (CRC) and head and neck (HNSCC) cancers. Cetuximab exerts its antitumor activity by blocking ligand-dependent EGFR signaling and by engaging immune effector mechanisms. To investigate cetuximab resistance mechanisms, we cultured the cetuximab-sensitive CRC cell line DiFi in 3D with cetuximab, generating the cetuximab-resistant derivative (DiFi-CR). Genomic and transcriptomic profiling revealed that DiFi-CR cells harbor a mutation of the S442 residue within the EGFR ectodomain. Patient samples revealed recurrent EGFR S442 mutations following anti-EGFR therapy, suggesting S442 as a potential resistance hotspot. For mechanistic analyses, we reconstituted the EGFR S442I mutation, using a doxycycline-inducible system, and showed that it was necessary and sufficient to induce cetuximab resistance in CRC and HNSCC cells using in vitro cultures and in vivo mouse experiments. In silico studies, live-cell binding assays, and antibody enrichment in nude mice xenografts revealed that the S442I mutation leads to weaker EGFR-cetuximab binding. Weaker cetuximab binding was also predicted in silico for other S442 patient mutations. We found that mutant EGFR-driven resistance could be overcome by targeting the EGFR family member ERBB2 with trastuzumab-deruxtecan. This combinatorial response required a physical interaction between EGFR and ERBB2, determined by co-immunoprecipitation. Our study supports EGFR S442 mutations as cetuximab resistance drivers and highlights co-targeting ERBB2 as a therapeutic strategy to restore anti-EGFR efficacy.

PubMedJournal of medical case reports2026-05-22

Complete remission following targeted therapy in BRAF V600E: mutant pulmonary lymphangitic carcinomatosis secondary to rectal cancer-a case report.

Dao Thi Thu Trang TTT, Tran Thi Thu Hien TTH, Nguyen Huu Loc HL, Nguyen Dinh Tung DT et al.

Pulmonary lymphangitic carcinomatosis (PLC) secondary to colorectal cancer is an uncommon manifestation, accounting for fewer than 7% of all PLC cases. Because of its nonspecific clinical and radiologic features, it is frequently misdiagnosed as interstitial lung disease or pulmonary infection. The prognosis remains poor, as the majority of patient's progress rapidly to acute respiratory failure shortly after diagnosis, with a reported median survival ranging from 2.2 to 7 months. To date, only one documented case has demonstrated survival beyond 12 months. Here, we present a patient who survived 19 months, emphasizing the importance of early recognition and the role of molecular-guided therapy in extending survival. We present a case of PLC secondary to rectal cancer harboring a BRAF V600E mutation that achieved complete response after relapse with triple combination therapy (dabrafenib, trametinib and cetuximab). A 30-year-old Vietnamese woman presented with unresectable rectal carcinoma and multiple lymph node metastases. She was initially treated with FOLFOX plus bevacizumab, achieving a first complete response, followed by FOLFIRI plus bevacizumab. However, she subsequently developed progressive pulmonary lymphangitic carcinomatosis with impending respiratory failure. Given the BRAF V600E mutation, third-line treatment with a BRAF inhibitor and trametinib combined with cetuximab was initiated. This regimen led to rapid symptomatic improvement, with dyspnea resolving within 1 day, and resulted in a second complete remission, specifically of pulmonary lymphangitic carcinomatosis, which was maintained for 4 months. Despite subsequent disease progression, the patient achieved an overall survival of 19 months from the time of diagnosis. This case demonstrates that triple combination therapy may induce rapid and durable remission in PLC secondary to BRAF-mutated colorectal cancer. It underscores the importance of comprehensive molecular profiling in guiding personalized treatment for rare metastatic manifestations. Moreover, this report highlights the importance of timely, genomics-guided therapeutic decision-making and pragmatic adaptation of targeted strategies in managing aggressive BRAF V600E-mutant colorectal cancer, particularly in clinically complex and resource-constrained settings.

PubMedRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2026-05-21

Artificial intelligence classification of spatial CD8 + T-cell distribution on computed tomography in oropharyngeal cancer.

Haraldsson André A, Askmyr David D, Altunbulakli Can C, Nilsson Mikael M et al.

CD8 + T-cell presence and distribution in oropharyngeal cancer (OPC) reflects specific immune phenotypes and are linked to prognosis. Image processing methods such as convolutional neural networks (CNN) may enhance treatment decisions. From standard computed tomography (CT) images, this study evaluates radiomics in combination with machine learning models and CNN for prediction of spatially resolved CD8 + T-cell immune profiles and survival outcomes. Pre-treatment CT images were analysed using and comparing radiomics and CNNs to predict stroma-to-cancer cell islet CD8 + T-cell infiltration ratios (SIR) and immune phenotypes as determined from spatially resolved tissue-array. Open data with genomic and image information were used for external validation. Further, we predicted survival outcomes stratified with our model in OPC patients recruited to the ARTSCAN III randomised clinical trial, which compared cetuximab with cisplatin concurrent with radiotherapy. Our CNN model achieved an area under the curve (AUC) of 0.75 (range 0.71-0.81) in predicting high versus low SIR, performing better than radiomics. When stratifying the ARTSCAN III patients according to the CNN-derived immune scores, patients with an inflamed phenotype had improved local control (HR 0.03, 95% CI 0-0.23, p < 0.0001), progression-free survival (PFS) (HR 0.36, 95%CI 0.18-0.71, p = 0.003), and overall survival (HR 0.35, 95%CI 0.14-0.85, p = 0.02) in univariable and multivariable analyses. When stratifying the ARTSCAN III patients by type of chemotherapy, high immune score classification corresponded to better PFS in cetuximab-treated patients. Our findings indicate the potential of CNNs to predict CD8 + T-cell infiltration in OPC, offering a promising non-invasive tool for treatment stratification and personalised therapy.

PubMedChemistry (Weinheim an der Bergstrasse, Germany)2026-05-21

Synthesis and Biological Evaluation of Well-Defined M6P(n)-Modified Glycopeptides for Targeted Protein Degradation.

Lenartowicz Patrycja P, Langenbach Jan-Willem H JH, Voloshyna Nataliia N, Aidukas David D et al.

Lysosome-targeting chimeras (LYTACs) is an emerging therapeutic strategy to deplete circulating and cell-surface proteins. It harnesses endocytic receptors, such as the cation-independent mannose-6-phosphate receptor (CI-M6PR), to direct a protein of interest for lysosomal degradation. We have developed a synthetic methodology to prepare multifunctional M6PR-targeting glycopeptides of varying valency using common building blocks. Peptides were prepared having one to six 4-methyltrityl (Mtt)-protected lysine moieties that could selectively be removed to give amines that were coupled with mannose-6-phosphate (M6P), mannose-6-phosphonate (M6Pn) and mannosyl building blocks having an α-configured anomeric 2-(2-(2-(2-hydroxyethoxy)ethoxy)ethoxy)acetic acid. The hydroxyls, phosphate and phosphonate of the building blocks were protected as p-methylbenzyl, which exhibited excellent stability during synthesis but could be removed under mild conditions without affecting sensitive functionalities. The glycopeptides have an azido lysine moiety for functionalization by strain-promoted azide-alkyne cycloaddition (SPAAC). Cetuximab (Ctx) was functionalized with bicyclo[6.1.0]non-4-yne for conjugation to M6P and M6Pn containing peptides via SPAAC. The resulting mAbs were examined for cellular uptake of soluble Epidermal Growth Factor Receptor (EGFR). Only mABs modified by glycopeptides carrying three or six M6P or M6Pn residues significantly increased uptake. Phosphonates were more efficient in removing cell surface EGFR by Ctx modified by tri- or hexavalent M6P or M6Pn ligand.

PubMedResearch in pharmaceutical sciences2026-05-21

Novel nanoliposomes for targeted codelivery of three anticancer agents against head and neck squamous cell carcinoma.

Mohammadi Maryam M, Tofighi Fahimeh Bagheri FB, Saatloo Maedeh Vakili MV, Talebi Mehdi M et al.

Head and neck squamous cell carcinoma (HNSCC) is a malignant tumor in which the overexpression of epidermal growth factor receptor (EGFR) is associated with malignancy. For the treatment of HNSCC, cetuximab (CIT) as an anti-EGFR antibody is prescribed in combination with anticancer chemotherapy drugs for greater effectiveness. In this work, a CIT-targeted immunoliposome loaded with cisplatin (CP) and docetaxel (DTX) was developed to allow co-administration of the antibody and the anticancer chemotherapy drugs and selective delivery to HNSCC cells. Developed immunoliposomes were characterized for particle sizes, PDI, zeta potential, surface morphologies, and encapsulation efficiency. Moreover, additional in vitro studies were conducted, including cytotoxicity against HN5 cell line, and cellular uptake studies. The final targeted liposomes exhibited an average diameter of 68.65 ± 3.4 nm; PDI and zeta- potential were respectively around -7.9 ± 1.7 mV and 0.35 ± 0.05. The encapsulation efficacy of DTX and CP within the immunoliposomes was approximately 95 ± 4% and 85 ± 4%, respectively. Flow cytometric analysis revealed that the cellular uptake rate of final immunoliposomes was significantly higher than that of the naked liposomes, indicating that CT conjugation on the surface of nanoliposomes facilitated higher accumulation via receptor-mediated endocytosis. Moreover, co-encapsulation of CP and DTX into CIT-immunoliposomes increased the apoptosis by 24.06% compared to single-drug nanoformulations. The results indicated that nanoliposomes anchored with CIT enhanced drug accumulation and cytotoxicity in cancer cells and reduced the likelihood of adverse side effects, paving the way for more effective cancer therapies.

PubMedJournal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG2026-05-20

Response to a combination therapy of cemiplimab and cetuximab in cutaneous squamous cell carcinoma - a case report.

Schabet Katja K, Schielein Louisa L, Enk Alexander A, Hassel Jessica C JC

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