Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer
March 31, 2017 -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 31, 2017 Category: Drugs & Pharmacology Source Type: news

HER2 and Decision Making in Gastroesophageal Adenocarcinoma HER2 and Decision Making in Gastroesophageal Adenocarcinoma
This new guideline provides specific recommendations for assessment of HER2 status in patients with advanced gastroesophageal adenocarcinoma.American Journal of Clinical Pathology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 28, 2017 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

KISQALI ® (ribociclib) Approved for the Treatment of HR+/HER2- Advanced Breast Cancer, available for order at Biologics, Inc.
CARY, N.C. (March 17, 2017) —Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by Novartis to be a specialty pharmacy provider for KISQALI® (ribociclib). (Source: McKesson News)
Source: McKesson News - March 17, 2017 Category: Information Technology Source Type: news

KISQALI (ribociclib) Approved for the Treatment of HR+/HER2- Advanced Breast Cancer, available for order at Biologics, Inc.
CARY, N.C. (March 17, 2017) —Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by Novartis to be a specialty pharmacy provider for KISQALI® (ribociclib). (Source: McKesson News)
Source: McKesson News - March 17, 2017 Category: Information Technology Source Type: news

HER2 Guidelines for Breast Cancer Could Misclassify Some Patients
The ASCO-CAP guidelines for HER2 gene amplification testing leave some patients at risk for misclassification and inappropriate treatment. (Source: CancerNetwork)
Source: CancerNetwork - March 16, 2017 Category: Cancer & Oncology Authors: Bryant Furlow Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

FDA Approves Ribociclib for First-Line Metastatic Breast Cancer
The FDA has approved ribociclib in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with advanced, HR-positive/HER2-negative breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - March 15, 2017 Category: Cancer & Oncology Tags: Breast Cancer News Source Type: news

Kisqali ® (ribociclib) for the Treatment of HR+/HER2- Metastatic Breast Cancer
Formerly known as LEE011, Kisqali ® (ribociclib) is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor indicated for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer i … (Source: Drug Development Technology)
Source: Drug Development Technology - March 15, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves Kisqali for Advanced HR+ Breast Cancer FDA Approves Kisqali for Advanced HR+ Breast Cancer
The new drug becomes the second in this class of agents for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 14, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Novartis Kisqali receives FDA approval for HR+ / HER2- metastatic breast cancer
Swiss-based healthcare company Novartis has received approval from the US Food and Drug Administration (FDA) for its Kisqali (ribociclib) in combination with an aromatase inhibitor as the first-line treatment of advanced or metastatic breast cancer. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - March 14, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer
Basel, March 13, 2017 - The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 13, 2017 Category: Drugs & Pharmacology Source Type: news

Can Less Costly 9-Week Trastuzumab Match Efficacy of 12-Month Regimen?
A cost-effectiveness analysis found that 9 weeks of trastuzumab therapy is better than the more standard 12 months in patients with HER2-positive breast cancer, without loss of clinical efficacy. (Source: CancerNetwork)
Source: CancerNetwork - March 8, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Practice & Policy Source Type: news

City of Hope researchers discover how breast cancer spreads to the brain
(City of Hope) Ninety percent of cancer deaths are from cancer spread. Breast cancer patients, for example, typically do not die because cancer returns in their breast, they die because it spreads to other parts of their body. The most dangerous of which is the brain. Approximately 40 percent of all women with HER2-positive breast cancer will develop brain metastases. Now City of Hope researchers have found how this happens. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - March 2, 2017 Category: Cancer & Oncology Source Type: news

Possible to Reduce Treatment Burden in HER2-Positive Breast Cancer?
This video examines the idea of using clinical features (age, tumor size) to reduce treatment burden in patients with HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - March 1, 2017 Category: Cancer & Oncology Authors: Sara M. Tolaney, MD, MPH Tags: Videos Breast Cancer Source Type: news

Adjuvant Chemotherapy Options in HER2-Positive Breast Cancer
This video examines chemotherapy options for HER2-positive breast cancer in the adjuvant setting, and what evidence there is for alternatives to an anthracycline backbone. (Source: CancerNetwork)
Source: CancerNetwork - March 1, 2017 Category: Cancer & Oncology Authors: Sara M. Tolaney, MD, MPH Tags: Videos Breast Cancer Source Type: news

Bevacizumab not cost effective for HER2-negative mBC
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - March 1, 2017 Category: Drugs & Pharmacology Source Type: news

AstraZeneca announces positive results from Phase III trial of Lynparza for breast cancer
Biopharmaceutical firm AstraZeneca has announced positive results from its Phase III clinical trial (OlympiAD) of Lynparza (olaparib) to treat patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. (Source: Drug Development Technology)
Source: Drug Development Technology - February 20, 2017 Category: Pharmaceuticals Source Type: news

Novel HER2 Inhibitor Offers Manageable Toxicity, Anti-Tumor Activity in Metastatic Breast Cancer
A phase I trial found that the HER2 inhibitor ONT-380 had a lower incidence of certain adverse events associated with this class of agent and notable anti-tumor activity in heavily pretreated patients with HER2-positive metastatic breast cancer (MBC). (Source: CancerNetwork)
Source: CancerNetwork - February 7, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

South Africa: Tobeka Daki Died Fighting Roche. Her Death Will Not Be in Vain.
[Daily Maverick] On World Cancer Day on February 4, 2016, the Fix the Patent Laws coalition in South Africa launched the Campaign for Access to Trastuzumab to advocate for broad access to the WHO-recommended essential treatment for early stage and metastatic HER2+ breast cancer. One year later we are renaming the campaign the Tobeka Daki Campaign in memory of the woman who led our advocacy for trastuzumab during 2016 - while herself unable to access the potentially life-saving treatment. By NKHENSANI MAVASA and CATHERINE T (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 7, 2017 Category: African Health Source Type: news

Inconsistencies With Assays for Resolving HER2 Status Inconsistencies With Assays for Resolving HER2 Status
This study compared the performance of two different reflex in situ hybridization assays and a real-time PCR assay for resolving HER2 status in a series of HER2-equivocal breast cancers.American Journal of Clinical Pathology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 24, 2017 Category: Consumer Health News Tags: Pathology & Lab Medicine Journal Article Source Type: news

Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial
This piece of research has lead to a practice changing update on DynaMed Plus. It concludes that the addition of trastuzumab biosimilar to taxane-based chemotherapy is associated with similar overall response and survival rates compared to addition of trastuzumab in women with HER2-positive metastatic breast cancer (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 20, 2017 Category: Consumer Health News Source Type: news

U. Colorado Cancer Center Trial Shows Tucatinib Progressing in Pivotal...
Twenty-seven percent of 50 heavily pretreated patients with stage IV HER2+ breast cancer saw clinical benefit from the drug, with at least “stable disease” at 24 or more weeks after the start of...(PRWeb January 11, 2017)Read the full story at http://www.prweb.com/releases/2017/01/prweb13972581.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - January 11, 2017 Category: Pharmaceuticals Source Type: news

Tucatinib (ONT-380) progressing in pivotal trial against HER2+ breast cancer
Twenty-seven percent of 50 heavily pretreated patients with stage IV HER2+ breast cancer saw clinical benefit from the drug Tucatinib (ONT-380) , with at least'stable disease'at 24 or more weeks after the start of treatment. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - January 11, 2017 Category: Science Source Type: news

Brain Mets Can Acquire HER2-Positivity in HER2-Negative Breast Cancer Patients
Brain metastases from primary breast cancer tumors often acquire clinically actionable genetic alterations, according to a small study. About one fifth of ERBB2/HER2-negative cases switched to HER2-positivity in the brain metastases. (Source: CancerNetwork)
Source: CancerNetwork - January 11, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Brain Tumors Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Tucatinib (ONT-380) progressing in pivotal trial against HER2+ breast cancer
(University of Colorado Anschutz Medical Campus) Twenty-seven percent of 50 heavily pretreated patients with stage IV HER2+ breast cancer saw clinical benefit from the drug, with at least 'stable disease' at 24 or more weeks after the start of treatment. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - January 10, 2017 Category: Cancer & Oncology Source Type: news

Glenmark receives IND application clearance to begin Phase I trial of GBR 1302-BEAT for HER2+ cancer
The US Food and Drug Administration (FDA) has cleared pharmaceutical company Glenmark ’s investigational new drug (IND) application to begin a phase I trial of GBR 1302-BEAT to treat HER2+ cancers. (Source: Drug Development Technology)
Source: Drug Development Technology - January 5, 2017 Category: Pharmaceuticals Source Type: news

Vaccine shows promising results for early-stage breast cancer patients
Immunotherapy is a fast growing area of cancer research. It involves developing therapies that use a patient's own immune system to fight and kill cancer. Medical researchers are working on a new vaccine that would help early-stage breast cancer patients who have HER2 positive disease. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - January 3, 2017 Category: Science Source Type: news

Vaccine shows promising results for early-stage breast cancer patients
Deregulation and inhibition of the immune system contributes to cancer development. Many therapeutic strategies aim to re-stimulate the immune system to recognize cancer cells and target them for destruction. Researchers from Moffitt Cancer Center report that a dendritic cell vaccine that targets the HER2 protein on breast cancer cells is safe and effectively stimulates the immune system leading to regression of early-stage breast cancer. (Source: World Pharma News)
Source: World Pharma News - January 3, 2017 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Anti-CDK4/6 Boosts PFS in Metastatic Breast Cancer (CME/CE)
(MedPage Today) --'Game changer'for HR-positive, HER2-negative disease (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - January 3, 2017 Category: Hematology Source Type: news

Vaccine shows promising results for early-stage breast cancer patients
(Moffitt Cancer Center) Immunotherapy is a fast growing area of cancer research. It involves developing therapies that use a patient's own immune system to fight and kill cancer. Moffitt Cancer Center is working on a new vaccine that would help early-stage breast cancer patients who have HER2 positive disease. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 3, 2017 Category: Global & Universal Source Type: news

Increased TIL Levels Associated With Better Outcomes in HER2-Positive Breast Cancer
A higher quantity of stromal tumor-infiltrating lymphocytes (TILs) was associated with better overall survival in patients with advanced HER2-positive breast cancer treated with either pertuzumab or placebo, along with trastuzumab and docetaxel. (Source: CancerNetwork)
Source: CancerNetwork - December 19, 2016 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Researchers use nanoparticles to overcome treatment-resistant breast cancer
Researchers from the University of Cincinnati College of Medicine have developed RNA nanoparticles that show promise in overcoming treatment-resistant breast cancer. The team’s work was published in ACS Nano.  The researchers used a nanocarrier to target HER2-positive breast cancer and stop the production of a specific protein to prevent metastasis and render the cancer cells vulnerable to tamoxifen, a therapy for estrogen-driven cancer. Get the full story at our sister site, Drug Delivery Business News. The post Researchers use nanoparticles to overcome treatment-resistant breast cancer appe...
Source: Mass Device - December 15, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Oncology Pharmaceuticals Research & Development University of Cincinnati Source Type: news

Breast Cancer After Hodgkin Lymphoma: The Price of Success
Curative therapy, including chest RT for Hodgkin lymphoma, is associated with a definitively increased risk of breast cancer, most often manifesting approximately 20 years after treatment. These breast cancers tend to be more aggressive, with greater frequency of hormone receptor negativity and potential HER2 positivity. (Source: CancerNetwork)
Source: CancerNetwork - December 15, 2016 Category: Cancer & Oncology Authors: Frederick Dirbas, MD Melinda L. Telli, MD Veronica Manzo, MD Tags: Breast Cancer Leukemia & Lymphoma Oncology Journal Source Type: news

In HER2- Breast Cancer, Brain Mets Are HER2+ 20% of Time In HER2- Breast Cancer, Brain Mets Are HER2+ 20% of Time
Metastases to the brain do not necessarily have the same molecular signature as primary breast tumors. Some are'wolves in sheep's clothing'and are targetable.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 15, 2016 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

AI Neither Adds nor Detracts From Chemo in This Setting AI Neither Adds nor Detracts From Chemo in This Setting
The addition of endocrine deprivation therapy to neoadjuvant chemotherapy doesn't increase pathologic complete response rates in hormone receptor-positive, HER2-positive breast cancer, but it doesn't diminish the effectiveness of chemotherapy either, as has long been believed.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2016 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Drug Combo Doubles PFS in Advanced Breast Cancer (CME/CE)
(MedPage Today) -- Everolimus-fulvestrant in metastatic ER-positive, HER2-negative disease (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - December 8, 2016 Category: Geriatrics Source Type: news

No Benefit in Adding AI to Neoadjuvant Treatment for HR+/HER2+ Breast Cancer
The addition of estrogen deprivation to neoadjuvant chemotherapy did not significantly affect pathologic complete response in women with HR-positive, HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - December 8, 2016 Category: Cancer & Oncology Authors: Leah Lawrence Tags: HER2-Positive Breast Cancer News Conferences/SABCS 2016 Source Type: news

Researchers identify biomarkers of response to treatment in invasive breast cancer
(UNC Lineberger Comprehensive Cancer Center) Researchers report at the San Antonio Breast Cancer Symposium that they have identified biomarkers they believe can be used as part of a larger model to predict how patients with HER2-positive operative breast cancer will respond to the targeted treatment trastuzumab, commercially known as Herceptin, and chemotherapy. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 8, 2016 Category: Cancer & Oncology Source Type: news

Adding Everolimus Doubles PFS in AI-Resistant Metastatic Breast Cancer
The addition of everolimus to fulvestrant was associated with more than a doubling of progression-free survival in women with metastatic hormone receptor –positive, HER2-negative breast cancer who were resistant to aromatase inhibitor therapy. (Source: CancerNetwork)
Source: CancerNetwork - December 7, 2016 Category: Cancer & Oncology Authors: Dave Levitan Tags: News Conferences/SABCS 2016 Source Type: news

A Breast Cancer Drug That Gets In The Brain? Cascadian Sees A Way Forward
Shutterstock Breast cancer patients sometimes end up dying when their tumors spread all the way to the brain. Some very good drugs already exist for patients with breast cancer, especially ones with tumors that overexpress the HER2 marker, but that success has raised a new question: Can drugmakers take another step, [...] (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - December 7, 2016 Category: Pharmaceuticals Authors: Luke Timmerman, Contributor Tags: NASDAQ:CASC NASDAQ:PBYI Source Type: news

Brain metastasis persists despite improved targeted treatment for HER2 breast cancer
(UNC Lineberger Comprehensive Cancer Center) While new targeted treatments developed across the past two decades have led to dramatic survival improvements for women with HER2-positive metastatic breast cancer, University of North Carolina Lineberger Comprehensive Cancer Center researchers and collaborators report that rates of breast cancer brain metastasis for women with this disease have not substantially declined. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 7, 2016 Category: Cancer & Oncology Source Type: news

Trastuzumab Biosimilar Yields Similar Response Rates in HER2-Positive Breast Cancer
A biosimilar yielded equivalent response rates to trastuzumab at 24 weeks in a study of women with HER2-positive metastatic breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - December 6, 2016 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

ACE Inhibitors, Beta-Blockers Could Mediate Trastuzumab Cardiac Toxicity
In patients with HER2-positive breast cancer undergoing trastuzumab therapy, the use of an ACE inhibitor or beta-blocker could protect against cardiac toxicity. (Source: CancerNetwork)
Source: CancerNetwork - December 1, 2016 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer Cancer Complications HER2-Positive Breast Cancer News Source Type: news

Palbociclib/Letrozole Significantly Delayed Progression in Advanced Breast Cancer
Patients with ER-positive, HER2-negative advanced breast cancer had significant delays in progression when palbociclib was added to letrozole treatment, according to the double-blind PALOMA-2 study. (Source: CancerNetwork)
Source: CancerNetwork - November 17, 2016 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Breast Cancer News Source Type: news

NHS to offer first new breast cancer drug for a decade
An estimated 1,380 women a year in England and Wales will benefit from the drug, which is given to patients with the HER2-positive form of breast cancer as soon as they are diagnosed. (Source: the Mail online | Health)
Source: the Mail online | Health - November 17, 2016 Category: Consumer Health News Source Type: news

Drug combination therapy for estrogen-receptor –positive breast cancer passes critical step for worldwide approval
Building on earlier clinical trials, UCLA researchers have confirmed that the “breakthrough” drug palbociclib when used in combination with the traditional hormonal therapy letrozole delays progression of advanced breast cancer significantly and without the harsh side effects seen in some women prescribed letrozole alone.The study, published online today in  the New England Journal of Medicine, is the phase 3 study following phase 1 and phase 2 clinical trials that led toU.S. Food and Drug Administration approval of palbociclib in early 2015. Palbociclib was also approved in Europe for the first time ...
Source: UCLA Newsroom: Health Sciences - November 16, 2016 Category: Universities & Medical Training Source Type: news

New Guidelines for HER2 Testing in Advanced Gastric Cancer New Guidelines for HER2 Testing in Advanced Gastric Cancer
Three professional organizations have jointly released comprehensive, evidence-based guidelines for HER2 testing in advanced gastric cancer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 15, 2016 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

FCGR3A Polymorphisms Predict Trastuzumab Benefit in HER2-Positive Breast Cancer
Polymorphisms in the FCGR3A gene are correlated with degree of benefit from trastuzumab in women with ERBB2/HER2-positive breast cancer, according to a new analysis. (Source: CancerNetwork)
Source: CancerNetwork - November 14, 2016 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

IBRANCE(R) (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer
NEW YORK--(Healthcare Sales & Marketing Network)--Pfizer Inc. (PFE) today announced that the European Commission (EC) has approved IBRANCE® (palbociclib) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor ... Biopharmaceuticals, Oncology, Regulatory Pfizer, IBRANCE, palbociclib, HR+/HER2, breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 10, 2016 Category: Pharmaceuticals Source Type: news

T-DM1 Offers Similar PFS, More Tolerable in Advanced HER2-Positive Breast Cancer
The antibody-drug conjugate trastuzumab emtansine (T-DM1) showed non-inferior —but not superior—efficacy to trastuzumab plus a taxane in women with advanced HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - November 9, 2016 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Elevated Troponin Tied to Increased Risk of Trastuzumab-Related Cardiac Dysfunction Elevated Troponin Tied to Increased Risk of Trastuzumab-Related Cardiac Dysfunction
Elevated baseline levels of troponin I and T are associated with an increased risk of trastuzumab-related cardiac dysfunction (TRCD) in women being treated for early-stage HER2-positive breast cancer, researchers report.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - November 4, 2016 Category: Intensive Care Tags: Pharmacist News Source Type: news