Drug Database
TR

trastuzumab (BP 02 / BP02)

✓ Approved

Aurobindo Pharma Limited · ERBB2 · Monoclonal Antibodies

What is trastuzumab?

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

Drug Profile

Brand NamesBP 02, BP02
CompanyAurobindo Pharma Limited
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetERBB2, LRP1
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Aurobindo Pharma Limited

Mechanism of Action

Molecular Targets

trastuzumab acts on 2 molecular targets:

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
LRP1LDL receptor related protein 1 (LRP1A, A2MR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

trastuzumab is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancerBLA/NDA

Related Research Articles

PubMedAmerican journal of ophthalmology2026-05-24

Clinical Features of Corneal Adverse Events Associated with Trastuzumab Botidotin: Payload-Driven Epitheliopathy and Neuropathy.

Zhang Yongyi Y, Tang Gege G, Zhang Jingjie J, Fu Yao Y et al.

HER2-targeted antibody-drug conjugates (ADCs) demonstrate significant efficacy in HER2-mutated or HER2-positive tumors but may cause ocular adverse events (AEs), particularly corneal epitheliopathy and blurred vision. This study aimed to characterize the clinical features of trastuzumab botidotin (a HER2-targeted ADC)-related corneal AEs. Retrospective case series. Eight adult patients (15 eyes) with HER2-mutated or HER2-positive solid tumors treated with trastuzumab botidotin. Assessments included best-corrected visual acuity (BCVA), Ocular Surface Disease Index (OSDI), Schirmer's test, tear break-up time (TBUT), tear meniscus height (TMH), and corneal fluorescein staining (CFS). In vivo confocal microscopy (IVCM) was performed to evaluate cellular structures and confirm lesion characteristics. Corneal AEs associated with trastuzumab botidotin and their clinical features. Corneal AEs occurred in all eight patients. The mean time to visual impairment onset was 37.25 ± 5.90 days after trastuzumab botidotin initiation, with symptom severity peaking at 82.75 ± 14.26 days. OSDI scores increased from 5.73 ± 2.67 at baseline to 65.10 ± 13.26 at peak severity. Trastuzumab botidotin caused dry eye in all patients (n = 8), resulting in reduced Schirmer's test results (from 8.94 ± 1.66 mm to 4.20 ± 1.58 mm), shortened tear break-up time (from 9.63 ± 1.21 s to 3.37 ± 1.61 s), and decreased TMH (from 0.23 ± 0.04 mm to 0.14 ± 0.02 mm). Slit-lamp microscopy and fluorescein staining revealed that trastuzumab botidotin induced distinct corneal epitheliopathy, characterized by pseudomicrocysts, punctate epitheliopathy, diffuse punctate epitheliopathy, and vortex keratopathy. IVCM correlated these findings, showing cyst-like hyperreflective structures in the superficial epithelium, grape-like hyperreflective clusters in wing cells and basal cells, and associated cellular disorganization. IVCM demonstrated neurotoxic damage, characterized by thinning of subbasal nerves, decreased nerve density, and focal discontinuities in the subbasal nerve plexus. Trastuzumab botidotin was associated with visual impairment, corneal epitheliopathy, and nerve damage. Close collaboration between ophthalmologists and oncologists is crucial for early detection of corneal AEs related to ADC therapy, thereby improving clinical outcomes and patient quality of life.

PMID 42176831
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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.

PMID 42176792
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PubMedActas dermo-sifiliograficas2026-05-24

Safety Profile of Systemic Therapy for the Management of Psoriasis in Patients With Diabetes Mellitus: Data From the BIOBADADERM Prospective Cohort.

Lluch-Galcerá Juan José JJ, Manuel Carrascosa José J, González-Quesada Alicia A, Sahuquillo Antonio A et al.

Patients with psoriasis and concomitant diabetes mellitus (DM) may be vulnerable to diabetes-related adverse events (DM-AEs). This study aimed to evaluate the incidence of DM-AEs associated with systemic treatments used in patients with psoriasis and DM. We conducted a prospective cohort study using data from the BIOBADADERM registry. We calculated incidence rates (IRs) of DM-AEs for each systemic treatment class, including biologics (tumor necrosis factor [TNF] inhibitors, interleukin [IL]-12/23 inhibitors, IL-17 inhibitors, and IL-23 inhibitors), conventional systemic therapies (methotrexate [MTX], cyclosporine, and acitretin), and apremilast (APR). The primary outcome was the adjusted incidence rate ratio (aIRR) for DM-AEs comparing patients receiving MTX with those receiving other systemic therapies using Poisson regression models adjusted for potential confounders. The study included 732 patients, 1401 treatment cycles, and 2865 person-years (PYs) of follow-up. APR (aIRR, 0.30; 95%CI, 0.10-0.60) was associated with a significantly lower risk of DM-AEs compared with MTX. Cyclosporine (aIRR, 7.50; 95%CI, 3.30-17.30) and acitretin (aIRR, 2.10; 95%CI, 1.20-3.70) were associated with a higher risk compared with MTX. Among patients with psoriasis and DM, APR was associated with a lower incidence of DM-AEs, whereas cyclosporine and acitretin were associated with higher incidences compared with MTX.

PMID 42177023
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PubMedAnnals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology2026-05-23

Depemokimab reduces asthma exacerbations similarly to other biologics: systematic trial review and indirect treatment comparison.

Bourdin Arnaud A, Pavord Ian D ID, Ballew Nicholas N, Butcher Brandon B et al.

Depemokimab is the first ultra-long-acting biologic, with efficacy and safety recently reported in the Phase III SWIFT-1/-2 studies including patients with type 2 asthma. To estimate the relative efficacy and safety of depemokimab versus other biologics via an indirect treatment comparison (ITC). The ITC evidence base was compiled via a systematic literature review (SLR) to identify randomized clinical trials on efficacy and safety of biologics in patients with severe asthma. Endpoints were analyzed using network meta-analysis (NMA; unadjusted) and multi-level network meta-regression (ML-NMR; partially/fully adjusted for clinically relevant/statistically feasible covariates including prior exacerbation history, inhaled/oral corticosteroid use and blood eosinophil count) and included annualized exacerbation rates (AER), adverse events (AEs) and serious AEs (SAEs). Overall, 17 and 22 trials were included in the exacerbation and safety analyses. Significant differences in efficacy were observed in the unadjusted fixed-effect model for depemokimab versus placebo, omalizumab, benralizumab, and dupilumab 300 mg, and in the partially adjusted fixed-effect model for depemokimab versus placebo and omalizumab. In the fully adjusted fixed-effect model, depemokimab significantly reduced AERs versus placebo; no significant differences were observed versus other biologics in this model. Odds of experiencing AEs and SAEs were similar across treatments, with fewer SAEs observed with depemokimab compared with dupilumab. Results were generally consistent across fixed- and random-effect approaches. In general, no statistically significant difference was detected between depemokimab and other biologics in terms of AER reduction or safety in severe asthma, including when adjusting for differences across studies in clinically important patient characteristics.

PMID 42173441
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PubMedEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2026-05-23

Local drug delivery for oral squamous cell carcinoma under oral cavity.

Ruslin Muhammad M, Cao Jiafu J, Ullah Muneeb M, Palungan Juliana J et al.

Oral squamous cell carcinoma (OSCC) is a leading malignancy within head and neck cancers and is associated with substantial morbidity and mortality. Local drug delivery systems (LDDS) have emerged as an important strategy to increase site-specific drug exposure at oral lesions while limiting systemic distribution and associated toxicity. However, therapeutic success in the oral cavity is constrained by stringent "hard constraints," including continuous salivary flow, enzymatic degradation, pH variability, and mechanical abrasion from chewing and tongue movement, which collectively reduce residence time and destabilize labile payloads. This review synthesizes major LDDS platforms for OSCC, including mucoadhesive films/patches, oral sprays, in situ gelling systems, and injectable hydrogels, and critically analyzes how platform performance is governed by interactions between payload properties (small molecules, biologics, nucleic acids), lesion characteristics (accessibility, geometry, margin control), and patient-centered factors. We highlight the need for decision-oriented frameworks that link clinical scenarios to platform selection and recommend standardized evaluation metrics for retention under salivary flow, resistance to mechanical stress, and biochemical stability in saliva-relevant conditions. Despite rapid progress in materials and delivery technologies, OSCC-specific optimization and translational testing remain limited. Future work should prioritize biocompatible, durable systems capable of maintaining predictable local exposure and controlled release under clinically relevant oral conditions, supported by rigorous preclinical validation and well-designed clinical studies to improve outcomes in OSCC.

PMID 42173451
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PubMedPediatric rheumatology online journal2026-05-23

Epidemiology and outcomes of non-infectious paediatric uveitis in the French Caribbean: a 15-year cohort study from a high-income health system in Martinique.

Felix Arthur A

Non-infectious uveitis (NIU) are rare in children but might be associated with substantial visual impairment. Most NIU paediatric cohorts originate from Europe, North America, or Asia, with minimal representation of Caribbean populations. Our study aimed to describe the epidemiology, clinical features, aetiologies and outcomes of paediatric NIU in Martinique. We conducted a monocentre, retrospective cohort study that included all children under the age of 18 diagnosed with NIU at the University Hospital of Martinique between 2010 and 2024. We identified cases through paediatric and ophthalmology registries, medical records, and national hospital databases. We excluded infectious uveitis and non-residents. Incidence estimates used population data. A total of 17 children with NIU were included in the study. 41% were male, with a mean age at diagnosis of 8.7 years (range: 2.5-16) and a median follow-up period of 7.6 years (range: 2.2-11.6). Eleven patients had anterior uveitis (64.7%), and 35.3% had panuveitis. Uveitis was unilateral in 64.7% of patients. The estimated incidence was 1.4 per 100,000 person-years (95% CI 0.83-2.27). The leading aetiology was juvenile idiopathic arthritis, accounting for 58.8% of cases. Systemic biologics were used in 17.6% of patients. Only one child experienced visual loss and required ocular surgery at the final follow-up. The first Caribbean paediatric NIU cohort shows a similar etiological spectrum and good visual outcomes as reported in high-income countries.

PMID 42174647
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