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US Oncology Research Plays an Important Role in the Clinical Development for NERLYNX ™ (Neratinib) Tablets
The Woodlands, Texas (September 12, 2017) — Early-stage breast cancer patients with HER2-positive tumors now have a promising new anti-HER2 treatment option in the extended adjuvant setting, thanks in large part to the efforts and expertise of US Oncology Research and McKesson Specialty Health. US O... (Source: McKesson News)
Source: McKesson News - September 12, 2017 Category: Information Technology Source Type: news

Abemaciclib: First-Line CDK4/6 Inhibitor for Breast Cancer Abemaciclib: First-Line CDK4/6 Inhibitor for Breast Cancer
Abemaciclib, the third CDK4/6 inhibitor, in combination with endocrine therapy shows significant benefit for the first-line treatment of HR+ HER2- advanced breast cancer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 11, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Oncolytics Biotech(R) Announces the Presentation of REOLYSIN(R) Clinical Data at ESMO 2017 Congress
Additional randomized phase 2 data in metastatic breast cancer demonstrates doubling of overall survival in Hormone Receptor Positive (ER+PR+)/HER2- patients Largest immuno-oncolytic virus safety database reported to-date demonstrates REOLYSIN® is s... Biopharmaceuticals, Oncology Oncolytics Biotech, REOLYSIN, breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 11, 2017 Category: Pharmaceuticals Source Type: news

Taselisib Added to Letrozole Boosts Response in Breast Cancer Taselisib Added to Letrozole Boosts Response in Breast Cancer
Taselisib, a PIK3CA targeted agent, in combination with letrozole significantly increased overall response rates in postmenopausal women with ER+/HER2- stage I-III operable breast cancer. ORRs were more robust in patients with PIK3CA mutations.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 10, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Amgen And Allergan Present Phase 3 Data On Biosimilar Trastuzumab Candidate ABP 980 At The European Society For Medical Oncology 2017 Congress
Study Between ABP 980 and Trastuzumab in Patients With HER2-Positive Early Breast Cancer Adds to the Totality of Evidence of Biosimilarity THOUSAND OAKS, Calif. and DUBLIN, Sept. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin® (trastuzumab) biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Results from the neoadjuvant efficacy phase of the study, including pathologic complete response ass...
Source: Amgen News Release - September 9, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

LORELEI: Taselisib boosts breast tumor shrinkage
(European Society for Medical Oncology) Adding taselisib to letrozole before surgery significantly improved outcomes for patients with early breast cancer that was both estrogen receptor positive and HER2-negative (ER+/HER2-) according to results of the LORELEI trial, presented at the ESMO 2017 Congress in Madrid. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 8, 2017 Category: International Medicine & Public Health Source Type: news

FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's DS-8201 for HER2-Positive Metastatic Breast Cancer
Breakthrough Therapy designation received for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-D... Biopharmaceuticals, Oncology, FDA Daiichi Sankyo, Breakthrough Therapy, DS-8201, breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 29, 2017 Category: Pharmaceuticals Source Type: news

Daiichi Sankyo and BMS to perform Phase Ib oncology combination trial
Daiichi Sankyo has entered a research collaboration to assess its investigational antibody drug conjugate (ADC) DS-8201 in combination with Bristol-Myers Squibb ’s (BMS) Opdivo (nivolumab) in a Phase Ib clinical trial to treat HER2-expressing metastat… (Source: Drug Development Technology)
Source: Drug Development Technology - August 28, 2017 Category: Pharmaceuticals Source Type: news

Faslodex (fulvestrant) Receives FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer
August 28, 2017 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 28, 2017 Category: Drugs & Pharmacology Source Type: news

Cynvenio Launches Newest LiquidBiopsy HER2 Expression Test
High sensitivity blood test allows measurement of HER2 over-expression in patients after primary tumor has been removed and tissue biopsy is no longer available - provides novel way to monitor...(PRWeb August 24, 2017)Read the full story at http://www.prweb.com/releases/2017/08/prweb14631277.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - August 24, 2017 Category: Pharmaceuticals Source Type: news

Nerlynx (neratinib) for the Treatment of Breast Cancer
Nerlynx ™ (neratinib) is a tyrosine kinase inhibitor indicated for the treatment of adult patients with early-stage HER2-overexpressed or amplified breast cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - August 23, 2017 Category: Pharmaceuticals Source Type: news

Alliance Foundation Trials opens global trial investigating first-in-class palbociclib in HR+, HER2+ metastatic breast cancer
The Alliance Foundation Trials, LLC (AFT), in conjunction with Pfizer and six international cancer research groups, have announced the launch of PATINA - a randomized, open-label, Phase 3 clinical study of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor palbociclib (also known as IBRANCE®). (Source: World Pharma News)
Source: World Pharma News - August 23, 2017 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Pyrotinib Promising in Phase I Metastatic HER2-Positive Breast Cancer Trial
A novel ErbB inhibitor called pyrotinib was well tolerated and showed promising activity in patients with metastatic HER2-positive breast cancer, according to results of a phase I trial. (Source: CancerNetwork)
Source: CancerNetwork - August 23, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Pfizer and AFT initiate Phase III trial of HER2+ breast cancer drug
Pfizer and the Alliance Foundation Trials have partnered with six international cancer research groups to initiate a Phase III clinical trial (PATINA) of palbociclib (IBRANCE) in patients with hormone receptor-positive (HR+), human epidermal growth f … (Source: Drug Development Technology)
Source: Drug Development Technology - August 22, 2017 Category: Pharmaceuticals Source Type: news

Clinical Laboratories May Need to Expand Test Portfolios with Companion and Complementary Diagnostic Assays as More Test-Dependent Drug Therapies Enter Market
However, the distinction between how the two different types of diagnostic tests are intended to be used still confuses many physicians and healthcare professionals Companion diagnostics are well-known to medical laboratorians. However, the new-breed of complementary diagnostics might not be as familiar. As the pharmaceutical pipeline increasingly becomes filled with test-dependent new drug therapies, medical […] (Source: Dark Daily)
Source: Dark Daily - August 21, 2017 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing anatomic pathology ANGLE Plc anti-HER2 Brandwidth Solutions Christopher Fikry MD clinical labo Source Type: news

Could Cytotoxic TILs Guide Treatment in Metastatic HER2+ Breast Cancer?
Low levels of cytotoxic stromal tumor-infiltrating lymphocytes are predictive of benefit derived from antibody- vs small molecule –based drug approaches to HER2-positive metastatic breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - August 9, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Medical News Today: New compound boosts treatment for aggressive breast cancer
A new anticancer agent, if given in combination with existing treatment, proves highly effective against triple negative and HER2 positive breast cancers. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - August 3, 2017 Category: Consumer Health News Tags: Breast Cancer Source Type: news

Targeting 'Achilles' heel' could supercharge breast cancer treatment
(Walter and Eliza Hall Institute) A new class of anti-cancer agents targeting cancer cells' 'Achilles' heel' could help to supercharge breast cancer treatment, improving outcomes for the most aggressive types of breast cancer.Combining anti-cancer compound S63845 with currently used cancer drugs was more effective in killing triple negative breast cancers and HER2-positive breast cancers.This is the first time the S63845 compound has been shown to be effective in breast cancer, suggesting it should be investigated in clinical trials. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - August 2, 2017 Category: Cancer & Oncology Source Type: news

A new HER2 mutation, a clinical trial and a promising diagnostic tool for metastatic breast cancer
There is a group of metastatic breast cancers that has the HER2 gene amplified - the cells have many copies of it - which leads to enhanced activity of the product enzyme, a tyrosine kinase. HER2 has been established as a therapeutic target in breast cancer, and breast cancers in which the HER2 gene is not amplified do not, in general, respond to HER2-directed therapeutic approaches. (Source: World Pharma News)
Source: World Pharma News - August 1, 2017 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

A new HER2 mutation, a clinical trial and a promising diagnostic tool for metastatic breast cancer
(Baylor College of Medicine) A phase II clinical trial of neratinib in patients with metastatic breast cancer carrying a HER2 mutation produces encouraging results in that about 30 percent of patients and a promising diagnostic tool for metastatic breast cancer. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 1, 2017 Category: International Medicine & Public Health Source Type: news

Amgen and Allergan Submit Biosimilar Biologics License Application for ABP 980 to US Food and Drug Administration
Filing for ABP 980, a Biosimilar Candidate to Herceptin® (trastuzumab), Supported by Phase 3 Data in Patients With HER2-Positive Early Breast Cancer THOUSAND OAKS, Calif., July 31, 2017 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AM... Biopharmaceuticals, Generics, Oncology, FDA Amgen, Allergan, ABP 980, Herceptin, (trastuzumab, Genentech, breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 31, 2017 Category: Pharmaceuticals Source Type: news

Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 980 To US Food And Drug Administration
Filing for ABP 980, a Biosimilar Candidate to Herceptin® (trastuzumab), Supported by Phase 3 Data in Patients With HER2-Positive Early Breast Cancer THOUSAND OAKS, Calif., July 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval. "The submission of AB...
Source: Amgen News Release - July 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Study finds HER2 breast cancer driver in 3 percent of lung cancers
A study by the University of Colorado Cancer Center found approximately 3 percent of lung cancer patients are found to have the HER2 breast cancer driver gene. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 27, 2017 Category: Consumer Health News Source Type: news

FDA Panel Backs Trastuzumab Biosimilar
The FDA Oncologic Drugs Advisory Committee has unanimously voted to recommend approval of the trastuzumab biosimilar MYL-1401O for the treatment of HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - July 27, 2017 Category: Cancer & Oncology Authors: Ian Ingram Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Study finds breast cancer driver, HER2, in 3 percent of lung cancers
(University of Colorado Anschutz Medical Campus) The Lung Cancer Mutation Consortium at the University of Colorado Cancer Center reports this week in the journal Cancer that 24 of 920 patients (3 percent) with advanced-stage lung cancer had mutations in the gene HER2. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - July 27, 2017 Category: Cancer & Oncology Source Type: news

NERLYNX (neratinib) Tablets Approved for HER2+ Breast Cancer in the Extended Adjuvant Setting
CARY, N.C. (July 21, 2017) — Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected to be in the limited distribution network for Puma Biotechnology, Inc.’s new product, NERLYNX, a kinase inhibitor approved by the U.S. Food and Drug Admi... (Source: McKesson News)
Source: McKesson News - July 21, 2017 Category: Information Technology Source Type: news

Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy
This research article has led to a Practice Changing Update on DynaMed Plus. It concludes that capecitabine adjuvant therapy may improve survival in women with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - July 19, 2017 Category: Consumer Health News Source Type: news

FDA Approves Neratinib for HER2-Positive Breast Cancer
The FDA has approved neratinib (Nerlynx) for use as extended adjuvant treatment in adult patients with early-stage HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - July 19, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

FDA Approves Nerlynx to Help Prevent HER2 + Breast CA Return
Drug is a kinase inhibitor that works by blocking several enzymes that promote cell growth (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - July 19, 2017 Category: Cancer & Oncology Tags: Gynecology, Oncology, Pharmacy, Institutional, Source Type: news

FDA approves Nerlynx to reduce risk of recurrent breast cancer
The U.S. Food and Drug Administration today approved the use of Nerlynx to treat early-stage HER2-positive breast cancer to lower remission risk. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 18, 2017 Category: Consumer Health News Source Type: news

Nerlynx Approved to Help Prevent Breast Cancer's Return
TUESDAY, July 18, 2017 -- Nerlynx (neratinib) has been approved by the U.S. Food and Drug Administration to help prevent HER2-positive breast cancer from returning. It's the first drug designed to prevent return of HER2-positive breast cancer, a... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 18, 2017 Category: General Medicine Source Type: news

FDA OKs First'Extended' Adjuvant Treatment for HER2 Breast Cancer FDA OKs First'Extended' Adjuvant Treatment for HER2 Breast Cancer
The FDA has approved a new drug for patients with early-stage HER2-positive breast cancer who have completed trastuzumab and want"extended" adjuvant therapy.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 17, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Neratinib Approved for Extended Adjuvant Breast Ca Treatment
(MedPage Today) -- Drug targets epidermal growth factor receptors HER2 and EGFR (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - July 17, 2017 Category: American Health Source Type: news

FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
July 17, 2017 -- The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 17, 2017 Category: Drugs & Pharmacology Source Type: news

FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab. (Source: Food and Drug Administration)
Source: Food and Drug Administration - July 17, 2017 Category: American Health Source Type: news

T-DM1 Promising as Neoadjuvant Therapy in Early BC (CME/CE)
(MedPage Today) -- 41% of HER2+/HR+ patients achieved a pathologic complete response (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - July 16, 2017 Category: Hematology Source Type: news

T-DM1 in Early HER2+/HR+ Breast Cancer Offers Good Response Rates
T-DM1 administered for 12 weeks with or without endocrine therapy yields good rates of pathologic complete response in women with HER2-positive/hormone receptor –positive breast cancer, according to a new randomized trial. (Source: CancerNetwork)
Source: CancerNetwork - July 14, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Oncologists See Promise in Neratinib, New Oral HER2-Positive Drug Oncologists See Promise in Neratinib, New Oral HER2-Positive Drug
Half of those asked in a Medscape survey rated neratinib, which is pending approval by the FDA later this month, as an important or very important alternative in treating HER2-positive breast cancer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 12, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

ASCO Panel Backs Gene Assay for Breast Cancer
(MedPage Today) -- MammaPrint OK'd for clinically high-risk HR-positive, HER2-negative disease (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - July 11, 2017 Category: Hematology Source Type: news

Puma closes patient enrolment in Phase III breast cancer trial of neratinib
Puma Biotechnology has completed patient enrolment in the Phase III NALA trial of its lead drug candidate PB272 (neratinib) for the treatment of HER2-positive metastatic breast cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - July 9, 2017 Category: Pharmaceuticals Source Type: news

Potential ASCO Practice-Changers in HER2+ Breast Cancer Potential ASCO Practice-Changers in HER2+ Breast Cancer
Oncologists will debate the APHINITY trial data for years to come, says Dr Kevin Kalinsky.Medscape Oncology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 7, 2017 Category: Consumer Health News Tags: Hematology-Oncology Commentary Source Type: news

Are Biobetters Better?
Biosimilars and biobetters are both variants of a biologic drug, however, while biosimilars are close copies of the originator, biobetters have been improved, for example, in terms of efficacy, safety, tolerability or dosing regimen.Regulators consider biobetters as new products and so afford them the same patent protection as any originator, however, this means they require the same clinical and non-clinical data packages. Conversely, a reduced clinical data package is an attractive element for the development of biosimilars.Given the cost of development and the time pressure to bring a biobetter to market before biosimil...
Source: EyeForPharma - July 3, 2017 Category: Pharmaceuticals Authors: James Wright Source Type: news

Abemaciclib Shows Activity for HR-Positive Breast Cancer Brain Mets
This video examines an early trial studying abemaciclib for the treatment of brain metastases in patients with hormone receptor –positive, HER2-negative breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - June 30, 2017 Category: Cancer & Oncology Authors: Sara M. Tolaney, MD, MPH Tags: News Videos Breast Cancer Source Type: news

Long-Term Data Confirm TH Benefit in Early HER2-Positive Breast Cancer
This video highlights 7-year follow-up data from the APT trial, which studied adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - June 30, 2017 Category: Cancer & Oncology Authors: Sara M. Tolaney, MD, MPH Tags: News Videos Breast Cancer Source Type: news

Novel Therapies in Development for HER2-Amplified Breast Cancer
In this interview we discuss some of the novel therapeutics in development for HER2-amplified breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - June 27, 2017 Category: Cancer & Oncology Authors: Sherene Loi, MD, PhD Tags: Breast Cancer HER2-Positive Breast Cancer Q & Source Type: news

Biosimilar for HER2-Positive Breast Cancer Equivalent to Trastuzumab
A biosimilar to trastuzumab known as CT-P6 showed equivalent efficacy and similar toxicity to the original agent in patients with HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - June 26, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

EMA Panel Likes Breast and Kidney Cancer Drugs EMA Panel Likes Breast and Kidney Cancer Drugs
The Committee for Medicinal Products for Human Use recommended approval of ribociclib for advanced HER+/HER2- breast cancer and tivozanib for advanced renal cell carcinoma.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 26, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Imagion Biosystems raises $9m with Aussie IPO
Imagion Biosystems (ASX:IBX) said today that it raised $9.1 million (A$12 million) in an initial public offering on the Australian stock exchange for its MagSense cancer-tagging nanoparticles. The 15.1¢-per-share (A20¢) flotation of 60 million shares is earmarked for 1st-in-human trials, expected during the 2nd half of 2018, the Albuquerque-based company said. The MagSense nanoparticles have a 25nm iron oxide core and a specialized polymer coating and are designed to work with tumor-targeting biomarkers to attach themselves to cancer cells. Because they behave differently when bound to a cell antibody than w...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Diagnostics Funding Roundup Initial Public Offering (IPO) Oncology Wall Street Beat imagionbiosystems Source Type: news

Adjuvant Capecitabine Improves Survival in Residual Invasive Breast Cancer
Patients with HER2-negative breast cancer with residual invasive disease following neoadjuvant chemotherapy benefit from adjuvant treatment with capecitabine. (Source: CancerNetwork)
Source: CancerNetwork - June 14, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer News Source Type: news