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

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AI-enabled lyophilization of advanced biologics: process intelligence, quality assessment, and formulation opportunities.

Liu Xiangjian X, Caprio Giuseppe Di GD, Du Yanan Y

Lyophilization is a key stabilization strategy for advanced biologics, including protein therapeutics, nucleic-acid-based products, extracellular vesicles, and other highly labile biopharmaceutical systems. However, the development of lyophilized biologic products remains constrained by the intrinsic complexity of coupled heat and mass transfer, limited real-time process observability, formulation-dependent instability, and the difficulty of linking process parameters to product-relevant critical quality attributes. In this context, artificial intelligence (AI) is emerging not merely as an auxiliary optimization tool, but as an enabling approach for data-driven process understanding, predictive quality assessment, and rational formulation-process development. This review focuses on recent progress and emerging opportunities at the intersection of AI-enabled lyophilization and advanced biologic preservation, with particular emphasis on process intelligence and formulation intelligence. We discuss how machine learning, computer vision, spectroscopy-integrated analytics, hybrid modeling, and digital twins are being explored to improve process modeling, state estimation, cycle optimization, defect detection, and critical quality attribute prediction, while highlighting formulation design as a strategically important but still early-stage frontier. We further propose that future progress in lyophilization of advanced biologics will increasingly rely on integrated frameworks that connect mechanistic knowledge, multimodal characterization, AI-assisted decision support, and product-relevant validation across both process development and formulation design.

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Research Advances in Drug Resistance Mechanisms to Anti-HER2 Therapy in HER2-Positive Breast Cancer.

Huang Chunwei C, Kong Jingyi J, Ren Hangxing H, Zhang Wanchen W et al.

HER2-positive breast cancer accounts for 15-20% of all breast cancer cases. Although the development of monoclonal antibodies (e.g., trastuzumab, pertuzumab), tyrosine kinase inhibitors (e.g., lapatinib, pyrotinib), and antibody-drug conjugates (e.g., T-DM1, trastuzumab deruxtecan) has greatly improved patient prognosis, primary or acquired resistance to anti-HER2 therapy remains a major clinical challenge, leading to treatment failure and disease progression. Recent research has elucidated diverse resistance mechanisms, including HER2 signaling pathway aberrations (such as receptor mutations, alternative splicing, and bypass activation), tumor microenvironment remodeling (involving immunosuppressive cells, metabolic reprogramming, and immune checkpoint molecules), and ADC-specific resistance (impaired internalization, lysosomal dysfunction, payload efflux, and ferroptosis blockade). However, existing reviews primarily focus on trastuzumab and classical signaling pathways, with insufficient integration of ADC-specific mechanisms or microenvironmental immune evasion. Furthermore, the translation of mechanistic discoveries into clinical strategies remains weak, and a systematic summary of validated biomarkers (e.g., PIK3CA mutations, PTEN loss, p95HER2, ADAR1, HLA-G) and related clinical trials is lacking. The purpose of this review is threefold: (1) to systematically integrate recent advances in anti-HER2 resistance mechanisms from three perspectives-HER2 signaling abnormalities, tumor microenvironment remodeling, and ADC-specific barriers; (2) to provide an evidence-based framework for target prioritization by categorizing mechanisms according to their validation stage (clinically validated, substantial in vivo evidence, or in vitro studies only); and (3) to summarize current biomarker-driven clinical trials and emerging therapeutic strategies, including combination immunotherapy, CDK4/6 inhibitors, PI3K PROTACs, and cold atmospheric plasma. Ultimately, this review aims to bridge the gap between basic research and clinical practice, offering practical guidance for overcoming anti-HER2 resistance through precision combination strategies in HER2-positive breast cancer.

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A Delphi Consensus on Clinical Features, Diagnosis, and Treatment of Chronic Rhinosinusitis With Nasal Polyps in the ASEAN Region.

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Preclinical in vitro and in vivo activity of trastuzumab deruxtecan against ERBB2-mutated cervical carcinomas with low HER2 expression.

Sethi Namrata N, Ottum Sarah S, Bellone Stefania S, Demirkiran Cem C et al.

Somatic HER2 mutations occur in up to 6% of cervical cancer patients and are associated with poor prognosis. We explored the activity of trastuzumab deruxtecan (T-DXd) as a novel targeted therapy against HER2-mutated primary cervical cancer cell lines and xenografts with low HER2 expression. HER2 expression was assessed by flow cytometry, while ERBB2 mutations were identified by whole-exome sequencing. Cytotoxicity was measured by flow cytometry-based viability assays, and double-stranded DNA breaks were evaluated using anti-phosphorylated-histone H2AX antibody. Bystander effect was assessed by co-culturing HER2-S310F-mutated (CVX4) and non-mutated (CVX8) tumor cells. In vivo, efficacy was tested over 47 days in severe combined immunodeficient mice bearing CVX4-xenografts (n = 4 in each group). All eight primary cell lines available demonstrated low HER2 expression. CVX4 (HER2-S310F activating mutation) was significantly more sensitive to T-DXd than control antibody-drug conjugate (CTL-ADC) as demonstrated in the cytotoxicity experiments (p = 0.0036) and double-stranded DNA break assays (p = 0.0057). CVX3, a tumor with a HER2 mutation of unknown significance (HER2-E405D) and CVX8 (HER2-non-mutated) showed no difference in sensitivity to the ADC. T-DXd induced substantial bystander killing in the co-culture (p = 0.0223) while in vivo, a single retroorbital injection of T-DXd (4 mg/kg) was well tolerated and achieved remarkable growth inhibition compared with CTL-ADC in CVX4-xenografts (p < 0.0001). T-DXd was shown to be highly active against HER2-S310F-mutated cervical cancer cell lines and xenografts. T-DXd may represent a novel, effective therapeutic option for recurrent cervical cancer patients harboring mutations in the ERBB2 gene, regardless of low HER2 expression.

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Step-DAWN: an Italian algorithm proposed for the management of inhaled corticosteroids in severe asthma.

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Biologics have transformed the management of severe asthma, establishing clinical remission as a realistic treatment objective. Moreover, they offer the potential to reduce background treatment with inhaled corticosteroids (ICS). Although guidelines recommend ICS dose reduction in patients achieving disease control, they provide limited guidance on how to implement tapering. In this context, we developed Step-DAWN (De-escalation of ICS in Asthma With a Novel algorithm), a consensus-based protocol that guides ICS tapering in adults with severe asthma receiving biologic therapy. Step-DAWN was ideated through a modified Delphi process; a Steering Committee consisting of two Italian specialists and two pharmaceutical Medical Affairs professionals drafted 30 statements, which were voted by an Expert Panel comprising 12 specialists. Consensus was reached on 21 of 30 statements in the first round; three other statements reached consensus in the second round; six statements did not reach consensus. The Step-DAWN protocol was designed based on 24 statements that achieved consensus. Patients eligible to Step-DAWN should have maintained the four criteria of complete clinical remission (cCR) for at least 6 months. ICS dose should be reduced gradually, with follow-up assessments not exceeding 6 months. In case of loss of eligibility criteria, potential causes should be addressed before reattempting tapering. Fractional exhaled nitric oxide (FeNO) and blood eosinophil count (BEC) were identified as key biomarkers for monitoring airway inflammation. Step-DAWN is the first consensus-based protocol designed by Italian specialists to provide guidance for ICS tapering in patients with severe asthma treated with biologics.

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