FDA approves Roche ’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

Roche today announced that the US Food and Drug Administration (FDA) has approved Kadcyla ® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin® (trastuzumab)-based treatment.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

Related Links:

Several clinicopathologic features of HER2-positive breast cancer patients were found to be associated with response to neoadjuvant therapy in a new study.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
AbstractABP 980 was developed as a biosimilar to trastuzumab, a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), that is indicated for the treatment of HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer. ABP 980 is approved in the United States, European Union, and Japan for all the indications of trastuzumab, based on the totality of evidence (TOE) gathered by the systematic step-wise accumulation of comparative analytical, preclinical, and clinical (pharmacokinetics [PK], efficacy, safety and immunogenicity) data for ABP  980 and trastuzumab...
Source: Targeted Oncology - Category: Cancer & Oncology Source Type: research
Is neoadjuvant T-DM1 plus pertuzumab associated with better event-free survival than conventional neoadjuvant therapy for HER2+ breast cancer?Journal of Clinical Oncology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
n Suwon Kim The therapeutic HER2-targeting antibody trastuzumab has been shown to elicit tumor immune response in a subset of HER2-positive (HER2+) breast cancer. We performed genomic and immunohistochemical profiling of tumors from eight patients who have completed multiple rounds of neoadjuvant trastuzumabb to identify predictive biomarkers for trastuzumab-elicited tumor immune responses. Immunohistochemistry showed that all tumors had an activated tumor immune microenvironment positive for nuclear NF-κB/p65RelA, CD4, and CD8 T cell markers, but only four out of eight tumors were positive for the PD-1 imm...
Source: Cancers - Category: Cancer & Oncology Authors: Tags: Article Source Type: research
Conclusion: Despite the low pCR rate, the tumor response and BCS conversion rates after NAC of luminal HER2- breast cancer were similar to those of other subtypes. NAC has the potential benefit of reducing the size of breast cancer, thereby increasing the BCS conversion rate in luminal HER2- breast cancer. PMID: 31598341 [PubMed]
Source: Journal of Breast Cancer - Category: Cancer & Oncology Tags: J Breast Cancer Source Type: research
Publication date: 8 October 2019Source: Cell Reports, Volume 29, Issue 2Author(s): Alison Hirukawa, Salendra Singh, Jarey Wang, Jonathan P. Rennhack, Matthew Swiatnicki, Virginie Sanguin-Gendreau, Dongmei Zuo, Kamilia Daldoul, Cynthia Lavoie, Morag Park, Eran R. Andrechek, Thomas F. Westbrook, Lyndsay N. Harris, Vinay Varadan, Harvey W. Smith, William J. MullerSummaryMonoclonal antibodies (mAbs) targeting the oncogenic receptor tyrosine kinase ERBB2/HER2, such as Trastuzumab, are the standard of care therapy for breast cancers driven by ERBB2 overexpression and activation. However, a substantial proportion of patients exhi...
Source: Cell Reports - Category: Cytology Source Type: research
Abstract Efficacy data from the KATHERINE clinical trial comparing ado-trastuzumab emtansine (T-DM1) to trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer with residual disease after neoadjuvant therapy (hazard ratio for invasive disease or death, 0.50; P
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
Authors: Skálová H, Hájková N, Majerová B, Bártů M, Povýšil C, Tichá I Abstract The importance of the expression profile of claudins in the molecular classification of breast cancer (BC) is currently under investigation. Claudins, together with cadherins, serve an important role in the epithelial-mesenchymal transition and influence the chemosensitivity of cancer cells. Adjuvant chemotherapy is administered following surgical resection in selected cases of BC. Previous neoadjuvant chemotherapy may change the molecular profile of a tumour and subsequent...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
In this study we aimed to examine the independent effect of baseline QoL and persistent CRT among pts with early BC.MethodsWe included data stage I-III BC pts treated with chemotherapy who were included in the CANTO prospective cohort study (NCT-01993498) from 03/2012 to 12/2014. The primary outcome was CRT defined as the presence at 3-6 months after the end of treatment, of any of the following toxicities (NCI-CTC-AE): infection, venous or arterial thrombosis, neurological G2-4, digestive G3-4 or pulmonary toxicities G3-4). Treatment deliver including chemotherapy dose reductions were also examined. The independent variab...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
AbstractBackgroundPathologic complete response (pCR) is a surrogate marker of a better relapse-free (RFS) and overall survival (OS), particularly in HER2 overexpressing and triple-negative breast cancer (TNBC) subtypes. Our aim is to assess the impact of HER2 expression level on pCR, in patients with luminal or TNBC treated with neoadjuvant chemotherapy (NAC).MethodsWe conducted a retrospective analysis in luminal and TN non-metastatic breast cancer patients, addressed to cancer center Georges Fran çois Leclerc in Dijon for NAC. Hormone receptor and HER2 expression were centrally assessed according to CAP/ASCO crite...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
More News: Breast Cancer | Cancer | Cancer & Oncology | Food and Drug Administration (FDA) | HER2 | Herceptin | Neoadjuvant Therapy | Pharmaceuticals