FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

April 4, 2019 -- Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for Ibrance (palbociclib) in combination with an aromatase inhibitor or...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news

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The combined use of a CDK4/6 inhibitor with endocrine therapy yielded a 9.4-month median OS benefit among patients.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
ConclusionsPredictive markers displayed a yearly similar distribution in breast cancer cases independently of grading or of intrinsic subtypes. These results point to a qualitative high performance of predictive marker assessment in breast cancer, corresponding to expected on average positivity rate per marker and per year. It is recommended to monitor positivity rate of ER, PR, Ki67 and Her2 yearly or periodically to comply with quality assurance requirements.
Source: Journal of Cancer Research and Clinical Oncology - Category: Cancer & Oncology Source Type: research
Publication date: Available online 16 October 2019Source: European Journal of RadiologyAuthor(s): Bas H.M. van der Velden, Tycho Bismeijer, Sander Canisius, Claudette E. Loo, Esther H. Lips, Jelle Wesseling, Max A. Viergever, Lodewyk F.A. Wessels, Kenneth G.A. GilhuijsAbstractPurposeTo retrospectively explore the relation between parenchymal enhancement of the healthy contralateral breast on dynamic contrast-enhanced magnetic resonance imaging (MRI) and genomic tests for estrogen receptor (ER)-pathway activity in patients with ER-positive/HER2-negative cancer.MethodsA subset of 227 consecutively included patients with unil...
Source: European Journal of Radiology - Category: Radiology Source Type: research
ConclusionsAgreement between MS and surrogate classifications was generally poor. However, a post hoc analysis showed that a combination of HG and Ki67 could identify patients very likely to have Luminal A tumours according to MS.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
ConclusionsmTOR signaling is highly activated in TNBC tumors. As single rapalog treatment is insufficient to block mTOR signaling in rapalog-resistant TNBC cells, our results thus provide a potential multi-kinase inhibitor combinatorial strategy to overcome mTOR-targeted therapy resistance in TNBC cells.
Source: Breast Cancer Research and Treatment - Category: Cancer & Oncology Source Type: research
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news
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
field Jacqueline A. Wilce Grb7 is an adapter protein, overexpressed in HER2+ve breast and other cancers, and identified as a therapeutic target. Grb7 promotes both proliferative and migratory cellular pathways through interaction of its SH2 domain with upstream binding partners including HER2, SHC, and FAK. Here we present the evaluation of a series of monocyclic and bicyclic peptide inhibitors that have been developed to specifically and potently target the Grb7 SH2-domain. All peptides tested were found to inhibit signaling in both ERK and AKT pathways in SKBR-3 and MDA-MB-231 cell lines. Proliferation, migration, ...
Source: Molecules - Category: Chemistry Authors: Tags: Article Source Type: research
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
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