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

PubMedTherapeutic advances in respiratory disease2026-09-19

Blood eosinophils in COPD: are biologics for everyone?

Vanetti Marco M, Visca Dina D, Ardesi Francesco F, Taglioretti Antonia M AM et al.

Type 2 (T2) biologics represent a promising treatment option for chronic obstructive pulmonary disease (COPD) patients with eosinophilic inflammation. To evaluate the prevalence of stable COPD patients who may be eligible for T2 biologics. Real-world, retrospective, monocentric study in COPD patients undergoing inpatient pulmonary rehabilitation. Clinical, functional, and inflammatory data were collected. Patients were considered eligible for T2 biologic therapy whether they were receiving optimized inhaled therapy and had a history of ⩾2 moderate and/or ⩾1 severe exacerbations in the previous year, together with a blood eosinophil count ⩾300 cells/μL. Among 441 patients, 21.5% had blood eosinophil counts ⩾300 cells/μL and 6.8% fulfilled the combined eligibility criteria. A high burden of respiratory and cardiometabolic comorbidities and increased cardiovascular risk was observed in the overall population. Only a subgroup of patients seems eligible for biologics, treatment escalation should be based on optimized standard care management and patient phenotyping.

PMID 42760892
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PubMedOcular immunology and inflammation2026-09-18

Biologic Therapy in Refractory Non-Infectious Uveitis: An Analysis of 60 Cases at a Tertiary Eye Care Centre from South India.

Agrawal Mohini M, Raghu Keerthana K, Kaushik Viswanath V VV, Vashisht Prashant P et al.

To evaluate the effectiveness and safety of biologic therapy in patients with refractory non-infectious uveitis (NIU) in a real-world clinical setting. A retrospective observational study was conducted at a tertiary eye care centre in South India between 2022 and 2025. Patients diagnosed with NIU, who were not responding to conventional treatment and had received biologics during this period, were included. Demographic details, anatomical classification, etiological diagnosis, type of biologic used, treatment duration, clinical outcomes, and adverse events were analysed. A total of 60 patients with refractory NIU receiving biologic therapy were included. The mean age at biologic initiation was 23.1 ± 13.7 years, comprising 27 (45%) paediatric and 33 (55%) adults. The mean duration of uveitis prior to biologic initiation was 34.48 ± 52.36 months. Anterior uveitis was the most common (40%). Autoimmune etiologies predominated, with juvenile idiopathic arthritis-associated uveitis (28.3%), HLA-B27-associated uveitis (23.3%), and Behçet disease (20%). Adalimumab was the most frequently used biologic agent (88.3%) followed by Infliximab (5%), golimumab (3.3%) and tocilizumab (3.3%). Biologic therapy resulted in significant control of intraocular inflammation (p < 0.0001). Visual acuity remained stable throughout the follow-up. Treatment modification was required in 7 patients (11.7%). Side effects were observed in 3 (5%) patients, 2 (3.3%) showed inadequate response and 2 patients (3.3%) discontinued biologics due to financial constraints. Biologic therapy is an effective and safe therapy for refractory non-infectious uveitis across all age-groups and etiologies. Early escalation to biologics may help arrest long-term cumulative inflammatory damage and preserve visual function by sustained inflammatory control.

PMID 42755380
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PubMedChinese medical journal2026-09-18

Improved diagnostic capability, rather than biologics, reduces surgical rates in Chinese Crohn's disease patients: A multicenter study.

Wan Jian J, Wang Zhuo Z, Shen Jun J, Zhong Jie J et al.

Surgical rates for Crohn's disease (CD) are declining globally. However, the driving factors remain unclear, particularly in newly industrialized countries. We aimed to evaluate the impact of diagnostic capacity and treatment with biologics on surgical rates among Chinese CD patients. Data of CD patients from January 2000 to January 2024 were extracted from 8 sites of the Chinese database for inflammatory bowel disease. Trends in cross-sectional imaging use, surgically diagnosed proportion, medical treatment, and surgery for CD were described. Cumulative surgical rates were compared using Kaplan-Meier method with log-rank test. Time-dependent Cox models were used to identify factors associated with surgery risk, and propensity score matching (PSM) was applied to validate the findings. In total, 1354 patients were included, with a median follow-up of 5.99 years. The cumulative 5-year surgical rate decreased from 30.96% in 2000-2012 to 21.57% in 2013-2024 (log-rank P <0.001). The use of cross-sectional imaging increased from 2.00% in 2000-2004 to 82.81% in 2020-2024. The proportion of surgically diagnosed patients declined from 13.68% in 2000-2012 to 6.21% in 2013-2024. Multivariate Cox analysis showed that diagnosis in 2013-2024 (hazard ratio [HR] 0.74, 95% confidence interval [CI]: 0.59-0.91, P = 0.006) was independently associated with a lower risk of surgery, whereas biologic use (HR 0.93, 95% CI: 0.71-1.22, P = 0.604) was not. Sensitivity analyses excluding surgically diagnosed patients demonstrated similar surgical rates between the two cohorts. PSM and subgroup analyses confirmed these trends. Surgical rates among Chinese CD patients have significantly decreased over the past two decades, in parallel with improvements in diagnosis. Enhancements in diagnostic pathways within broader systemic healthcare upgrades are strongly associated with reduced surgical risk, whereas increased use of biologics is not.

PMID 42754551
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PubMedCurrent opinion in pulmonary medicine2026-09-18

Eosinophils in bronchiectasis.

Trieu Megan M, Akuthota Praveen P, Barry Jeffrey J

Bronchiectasis has traditionally been viewed as a predominantly neutrophil-driven airway disease. Recognition of eosinophilic inflammation in a substantial subset of patients has challenged this paradigm. This review summarizes emerging evidence regarding its pathogenesis, clinical significance, and therapeutic implications. Eosinophilic bronchiectasis is identified using blood or sputum eosinophilia, although optimal biomarkers and thresholds are unclear. Eosinophilic inflammation occurs in bronchiectasis and overlapping disease states characterized by type 2 immune activation, including asthma, allergic bronchopulmonary aspergillosis, and cystic fibrosis, complicating diagnosis but potentially informing disease severity, prognosis, and treatment options. Evidence for targeted therapies is limited to largely observational data. Patients with elevated eosinophil counts may derive greater benefit from inhaled corticosteroids. Early studies of biologics appear promising, particularly in patients with coexisting ABPA or asthma, although their benefit in eosinophilic bronchiectasis independent of these conditions remains uncertain. Eosinophilic bronchiectasis represents a distinct inflammatory endotype that may enable a more personalized approach to disease management. Future studies should identify clinically relevant biomarkers to standardize its definition, clarify its relationship with overlapping type 2 airway diseases, and guide the use of inhaled corticosteroids and biologics.

PMID 42755272
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PubMedFrontiers in medicine2026-09-18

Neoadjuvant pembrolizumab-based therapy versus dual HER2 blockade in early breast cancer: comparable surgical complication rates in a real-world cohort.

Wimmer Kerstin K, Kantner Katharina K, Exner Ruth R, Bartsch Rupert R et al.

Neoadjuvant systemic therapy (NST) has become a cornerstone in the management of aggressive early breast cancer (BC) subtypes, including triple-negative (eTNBC) and HER2-positive disease. Immune checkpoint inhibition with pembrolizumab represents an active immunotherapeutic approach, whereas dual HER2 blockade with trastuzumab and pertuzumab constitutes passive immunotherapy in early HER2-positive BC. Although both strategies demonstrate substantial antitumor efficacy, real-world data directly comparing their surgical safety profiles are limited. This retrospective single-center cohort study included 99 patients with early BC treated with NST between 2014 and 2025. A total of 33 patients with TNBC received pembrolizumab-based therapy according to the KEYNOTE-522 regimen, whereas 66 patients with HER2-positive disease received chemotherapy combined with trastuzumab and pertuzumab. Surgical adverse events within 30 days postoperatively were assessed using the Clavien-Dindo classification and the Comprehensive Complication Index (CCI). Complication rates and severity were compared between groups. The overall postoperative complication rate was 25.3%, with no significant difference between TNBC and HER2-positive cohorts (27.3% vs. 24.2%, p = 0.744). Most complications were minor (Clavien-Dindo ≤II), and rates of major complications (≥IIIa) did not differ between groups (p = 0.706). Mean CCI scores were comparable (22.1 vs. 24.4; p = 0.630). Seroma formation was the most frequent adverse event in both cohorts. In an exploratory multivariable logistic regression analysis, treatment group was not independently associated with postoperative complications. Pathological complete response rates were 63.6% in TNBC and 45.5% in HER2-positive patients. No clinically relevant delays in adjuvant radiotherapy occurred. No statistically significant differences in postoperative morbidity were observed between treatment groups. These findings support the feasibility of integrating both neoadjuvant treatment strategies into routine surgical practice; however, confirmation in larger prospective studies is warranted.

PMID 42755968
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PubMedClinical Medicine Insights. Oncology2026-09-18

Efficacy and Safety Ranking of HER2-Targeted TKIs in Advanced Breast Cancer: A Bayesian Network Meta-Analysis.

Li Rongjie R, Huangfu Rui R, Lan Hua H, Zhang Chenying C et al.

To compare the efficacy and safety of HER2-targeted tyrosine kinase inhibitors (TKIs) in patients with HER2-positive advanced or locally advanced breast cancer using a Bayesian network meta-analysis and to provide comparative evidence for individualized treatment decisions. PubMed, Embase, Web of Science, and the Cochrane Library were systematically searched for randomized controlled trials evaluating HER2-targeted TKIs in patients with HER2-positive advanced or locally advanced breast cancer. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR) were assessed as efficacy outcomes, while treatment-related adverse events were evaluated as safety outcomes. A Bayesian network meta-analysis was performed using R (version 4.2.2) and Stata (version 16.0). Treatments were ranked according to the surface under the cumulative ranking curve (SUCRA). The study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD420250650274). Fourteen randomized controlled trials involving 5,289 patients were included. According to SUCRA rankings, pyrotinib plus capecitabine (Pyrotinib_C) showed the highest probability of favorable ranking PFS, ORR, and DCR. Tucatinib combined with trastuzumab and capecitabine (Tucatinib_T_C) demonstrated the highest probability of favorable OS ranking. Regarding safety, pyrotinib combined with trastuzumab and capecitabine (Pyrotinib_T_C) was associated with the highest incidence of serious adverse events, diarrhea, and hand-foot syndrome, whereas Pyrotinib_C showed the highest incidence of anemia and lapatinib plus capecitabine (Lapatinib_C) demonstrated the highest incidence of rash. Among currently available HER2-targeted TKIs, Pyrotinib_C showed the highest probability of favorable ranking for PFS and tumor response outcomes, whereas Tucatinib_T_C showed the highest probability of favorable OS ranking. However, pyrotinib-containing regimens were associated with a higher risk of treatment-related toxicities. These findings highlight the importance of balancing efficacy and safety when selecting HER2-targeted TKI therapies and support individualized treatment strategies for patients with HER2-positive advanced breast cancer.

PMID 42756652
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