FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2+ Metastatic Breast Cancer

The agency is set to make a decision on the investigational antibody drug conjugate by the first quarter of 2020.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news

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Abstract Introduction: Clinicopathologic and prognostic significance of body mass index (BMI) in breast cancer (BC) patients remained conflicting. We aimed to investigate and modify the impact of BMI on clinicopathological significance and survival in western Chinese BC patients. Materials and Methods: 8,394 female BC patients from Western China Clinical Cooperation Group (WCCCG) between 2005 and 2015 were identified. Multivariable logistic regression and Cox proportion hazard regressions were used to examine the difference of clinicopathologic and survival characteristics between BMI categories. Results...
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
A new study confirms that a CDK4/6 blocker plus endocrine therapy is better than chemotherapy in young women with HR+, HER2- metastatic disease.Medscape Medical News
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
(European School of Oncology) Patients with HER2-positive breast cancer, whose disease has progressed after being treated initially with pertuzumab in combination with trastuzumab and a taxane, can respond well to treatment with T-DM1 -- a drug that combines trastuzumab with an anti-cancer drug called DM1. The research is presented at the Advanced Breast Cancer Fifth International Consensus Conference (ABC5) and published simultaneously in published in Clinical Breast Cancer journal.
Source: EurekAlert! - Cancer - Category: Cancer & Oncology Source Type: news
Conclusions: Use of the 21-gene rs assay could be a cost-effective strategy for Ontario patients with estrogen receptor-positive, her2-negative early bca and 1-3 positive lns. PMID: 31708649 [PubMed - in process]
Source: Current Oncology - Category: Cancer & Oncology Tags: Curr Oncol Source Type: research
In a new study, patients with HR+/HER2- early stage breast cancer completed 2 years of adjuvant palbociclib with a similar toxicity profile as that observed in the metastatic setting.Annals of Oncology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
AbstractPurpose of ReviewTo summarize and discuss the available evidence and ongoing efforts in order to establish the efficacy and safety of immunotherapeutic approaches in HER2-positive breast cancer.Recent FindingsThe introduction into the clinic of anti-HER2 –targeted therapies more than 15 years ago resulted in a substantial improvement in the outcome of patients with HER2-overexpressing breast cancer. However, only patients with the highest levels of HER2 expression will potentially benefit from these therapies and, unfortunately, many patients prog ress or relapse after optimal treatment. As metastatic breast ...
Source: Current Breast Cancer Reports - Category: Cancer & Oncology Source Type: research
AbstractBackground.Immune checkpoint inhibitors are active in a broad range of cancers, including programmed death ligand 1 (PD‐L1)‐positive, triple‐negative, metastatic breast cancer (MBC). Antibody‐dependent cell‐mediated cytotoxicity is a mechanism of action of trastuzumab. We performed a phase Ib trial of durvalumab and trastuzumab in HER2‐positive MBC previously treated with chemotherapy and anti‐HER2 antibodies to assess safety, efficacy, and correlative endpoints.Patients and Methods.Patients with HER2‐positive MBC were enrolled on a standard 3 + 3 design. Dose level 1 was durvalumab (1,125 mg intrav...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Breast Cancer Source Type: research
In this study a clinically meaningful prolongation of PFS by 2.2 months was observed. In addition, the time to intervention for brain metastases was prolonged in the neratinib group and the cumulative incidence of brain metastases was lower as well. On the downside a high rate of grade 2 and  3 diarrhoea was observed.
Source: Memo - Magazine of European Medical Oncology - Category: Cancer & Oncology Source Type: research
Conditions:   HER2-positive Breast Cancer;   Brain Metastases Interventions:   Drug: Afatinib;   Drug: T-DM1 Sponsor:   xuexin he Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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