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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

PubMedInternational journal of clinical oncology2026-07-22

Excitation-light blocking filter for photoimmunotherapy tailored to the ORBEYE 4K 3D exoscope.

Okada Ryuhei R, Kanebako Hideki H, Takahashi Ryosuke R, Nagahisa Taisei T et al.

Photoimmunotherapy, which involves combining targeted antibodies with light-activatable dyes such as IRDye700DX (IR700), is an emerging cancer treatment modality. Cetuximab-based photoimmunotherapy is approved for the treatment of unresectable head and neck cancer and has been covered by the national health insurance in Japan since 2021. Use of conventional ceiling surgical lighting during photoimmunotherapy is problematic due to concerns about potential cytotoxic effects. To ensure safe surgical application, we developed a custom short-pass filter for the ORBEYE surgical exoscope to block IR700 excitation light. The filter's impact on the color tone was evaluated using human skin and a color checker, while that on the cytotoxicity was assessed in vitro using cetuximab-IR700 and an HSC-3 cell line. The clinical feasibility of using this filter was tested in six patients who underwent short surgical procedures (e.g., tracheostomy, arterial ligation) during photoimmunotherapy. Recalibrating the white balance after filter placement preserved the natural color tones. In vitro, the filter neutralized the significant cytotoxicity observed under the ORBEYE light. Clinically, the filter could be used safely in all cases with no evidence of postoperative skin damage. This filter system enhances the safety and feasibility of surgical procedures during photoimmunotherapy.

PubMedCase reports in oncological medicine2026-07-22

Successful Sequential Multimodal Therapy for Lingual Rhabdomyosarcoma in a Young Adult: Case Report.

Dominguez Jonathan Villanueva JV, Arizmendi Josué Vázquez JV, Herrera Vianey Guadalupe Saldaña VGS, Morales Ivan Meneses IM et al.

Lingual rhabdomyosarcoma (RMS) in adults is an exceedingly rare malignancy, with very few cases reported and no standardized treatment guidelines. We present the case of a 19-year-old male diagnosed with lingual RMS who underwent sequential multimodal therapy. The patient initially received doxorubicin combined with ifosfamide chemotherapy followed by cisplatin combined with 5-fluorouracil, both of which resulted in disease progression. A third-line regimen with vincristine, actinomycin D, and cyclophosphamide (VAC) together with pembrolizumab achieved only transient stabilization and was limited by toxicity. Subsequent treatment with cetuximab together with bevacizumab induced a significant partial response with acceptable tolerance, which was consolidated with intensity-modulated radiotherapy (IMRT) to the primary site and cervical lymph nodes. Surveillance imaging confirmed durable locoregional control without evidence of systemic disease, whereas swallowing and phonation were preserved. This case illustrates the value of individualized stepwise management in adult RMS and suggests that the integration of immunotherapy and antiangiogenic therapy may provide meaningful tumor control and functional preservation in selected patients.

PubMedBMC cancer2026-07-21

Efficacy and safety of cetuximab-irinotecan rechallenge versus regorafenib in ras wild-type metastatic colorectal cancer: a single-center exploratory randomized trial.

Chen Hao H, Jiang Tao T, Wang Han H, Zheng Jianwei J et al.

Anti-epidermal growth factor receptor (EGFR) antibodies are widely used in the treatment of RAS wild-type metastatic colorectal cancer (mCRC) across various lines of therapy, including after disease progression. However, evidence from randomized controlled trials regarding the efficacy of cetuximab rechallenge in patients who initially responded to prior cetuximab but subsequently progressed after a cetuximab-free interval remains limited. This single-center, prospective, exploratory randomized trial (ChiCTR1900026961) evaluated cetuximab plus irinotecan rechallenge versus regorafenib in patients with RAS wild-type, microsatellite-stable mCRC who had previously responded to then progressed off cetuximab. Progression-free survival (PFS) was the primary endpoint, with overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety as secondary endpoints. Univariate and multivariate Cox regression analyses were performed to identify potential prognostic factors, and an exploratory nomogram was developed for hypothesis generation. Among 68 randomized patients, cetuximab plus irinotecan rechallenge was associated with longer median PFS and OS than regorafenib. The DCR and ORR were numerically higher in the rechallenge group. Median PFS was 5.5 months versus 2.6 months, and median OS was 18.8 months versus 10.4 months. Adverse events in the cetuximab group were predominantly grade 1-2 and manageable with supportive care. Univariate and multivariate analyses identified age, ECOG status, and cetuximab-free interval as potential prognostic factors. An exploratory nomogram was constructed based on these factors. These findings suggest that cetuximab plus irinotecan rechallenge may be associated with clinical benefit and acceptable toxicity in selected patients with RAS/BRAF wild-type mCRC. The exploratory nomogram requires further validation. These results support further investigation of rechallenge strategies and biomarker-guided approaches in advanced CRC. This study was registered with the Chinese Clinical Trial Registry on October 27, 2019 (registration number: ChiCTR1900026961).

PubMedOncotarget2026-07-21

WIN-MTB-2024017 - WIN International Molecular Tumor Board: A 48-year-old female with multiple primary cancers.

El-Deiry Wafik S WS, Hernando-Calvo Alberto A, Dizon Don D, Magidi Shai S et al.

Copyright: © 2026 El-Deiry et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Multiple primary cancers (MPC), the occurrence of two or more distinct malignancies in the same patient, pose significant clinical challenges due to their complexity and the need for individualized treatment strategies. This case, discussed at the WIN Consortium International Molecular Tumor Board, illustrates the clinical journey of a 48-year-old female with a BRCA1 germline mutation who developed multiple primary cancers: breast, skin, high-grade serous carcinoma of the ovary, colon and small bowel cancers. Her treatment history included doxorubicin and cyclophosphamide for breast cancer, Mohs surgery for basal cell carcinoma, and carboplatin and paclitaxel for ovarian cancer. After participating in the PRIMA trial with niraparib, she was diagnosed with PIK3CA-mutated colon cancer, leading to resection and CAPOX chemotherapy. A subsequent diagnosis of small bowel adenocarcinoma, molecularly resembling her colon cancer, along with a unique BRCA1-STARD3 fusion in inguinal lymph nodes prompted a comprehensive MTB review. The panel discussed several precision strategies, including combinations of cetuximab, niraparib, and temsirolimus; FOLFIRI with anti-EGFR inhibitors; anti-CTLA-4 and anti-PD-1 (botensilimab and balstilimab); regorafenib with anti-CTLA-4 and anti-PD-1 (ipilimumab and nivolumab); trifluridine/tipiracil with bevacizumab; regorafenib alone; aspirin for potential benefits in patients with PIK3CA mutations; therapies targeting PIK3CA and EGFR alterations; regular imaging and liquid biopsies assessments for monitoring disease progression and guide future treatment decisions; and vaccines targeting PIK3CA, STARD3 and TP53. This case underscores the complexity of managing MPC and highlights the essential role of international molecular tumor boards in generating innovative, tailored treatment recommendations for patients with rare and multifaceted disease courses.

PubMedThe oncologist2026-07-20

First report of dual KRAS Y96C/Y96S resistance mutations detected by liquid biopsy in KRAS G12C-mutant metastatic colorectal cancer.

Wang ZhiYu Z, Hong Dan D, Zhang Lan L, Qin Yan Y et al.

Acquired resistance limits the long-term efficacy of KRAS G12C inhibitors in metastatic colorectal cancer (mCRC). While feedback signaling is a known resistance driver, the clinical evolution of structural alterations within the drug-binding pocket remains poorly characterized. We present a patient with microsatellite-stable (MSS) KRAS G12C-mutated mCRC who progressed after 9.3 months of sequential KRAS G12C inhibitor monotherapy. Comparative molecular profiling of baseline tissue and post-progression plasma ctDNA identified the de novo emergence of concurrent KRAS Y96S and Y96C mutations. These polyclonal Switch II pocket alterations, absent in pretreatment specimens, indicated convergent evolution under therapeutic selective pressure. A rationale-based salvage therapy utilizing vertical MAPK pathway blockade (sotorasib, cetuximab, and trametinib) failed to achieve durable control (PFS: 1.9 months), confirming biological refractoriness. The acquisition of polyclonal KRAS Y96S/C mutations represents a definitive structural resistance mechanism that compromises the efficacy of intensified vertical pathway blockade. The discordance between tissue and liquid biopsy findings underscores the necessity of plasma-based monitoring to capture spatial heterogeneity. These findings suggest that overcoming convergent Switch II pocket remodeling requires next-generation inhibitors with distinct binding modes rather than further pathway intensification.

PubMedCancer chemotherapy and pharmacology2026-07-19

Correction to: The CetuxIMAX study: a population pharmacokinetic approach to modelling the pharmacokinetics and pharmacodynamics relationships of Cetuximab in patients with head and neck cancer.

Marin Clémence C, Deschamps Anthéa A, Gerbault Quentin Q, Toullec Clémence C et al.

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