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Trastuzumab: No negative impact on cardiac function
(NRG Oncology) Long-term follow-up results of the NRG Oncology trial NSABP B-31 have shown that the addition of trastuzumab to adjuvant chemotherapy does not negatively affect cardiac function in women with node-positive, human epidermal growth factor receptor 2 (HER2)-positive, early-stage breast cancer who survive without cancer recurrence. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 3, 2018 Category: International Medicine & Public Health Source Type: news

Ganetespib, Paclitaxel, Trastuzumab for HER2+ Breast Cancer Ganetespib, Paclitaxel, Trastuzumab for HER2+ Breast Cancer
Early research finds that ganetespib added to paclitaxel and trastuzumab shows promise for heavily pretreated patients with HER2+ breast cancer.Breast Cancer Research (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 2, 2018 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

For Low-Level HER2 Breast Cancer, Trastuzumab Is a No-Go For Low-Level HER2 Breast Cancer, Trastuzumab Is a No-Go
Although the study didn't turn out as hoped, NSABP B-47 will help inform the decision of whether patients with low-level HER2 breast cancer should receive trastuzumab.Medscape Oncology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 29, 2017 Category: Consumer Health News Tags: Hematology-Oncology Commentary Source Type: news

Mylan breast cancer drug approved in Brazil
Mylan NV on Friday said it had received the green light in Brazil for a treatment for breast cancer that it developed with a partner in the country. Biocon LTD (BSE: BIOCON) and Mylan (Nasdaq: MYL) co-developed biosimilar Trastuzumab, which treats overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. It will be sold in Brazil in Brazil as Zedora by Libbs Farmac eutica. "The approval of Zedora, Brazil's first Trastuzumab… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 29, 2017 Category: Pharmaceuticals Authors: Paul J. Gough Source Type: news

Mylan-Biocon's breast cancer biosimilar gets ANVISA nod
Biosimilar trastuzumab, indicated for breast cancer treatment, has been co-developed by Biocon and Mylan. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 29, 2017 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer
Roche today announced the US Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) at high risk of recurrence. (Source: Roche Media News)
Source: Roche Media News - December 21, 2017 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer
Roche today announced the US Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) at high risk of recurrence. (Source: Roche Investor Update)
Source: Roche Investor Update - December 21, 2017 Category: Pharmaceuticals Source Type: news

South Korea's Samsung Bioepis says FDA to review Herceptin copy
SEOUL (Reuters) - South Korea's Samsung Bioepis Co Ltd said on Wednesday the U.S. Food and Drug Administration (FDA) has accepted for review its copy of Swiss drugmaker Roche's blockbuster breast cancer drug Herceptin for potential approval. (Source: Reuters: Health)
Source: Reuters: Health - December 20, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Everolimus With Trastuzumab and Paclitaxel for HER2+ MBC Everolimus With Trastuzumab and Paclitaxel for HER2+ MBC
Is the combination of everolimus, trastuzumab, and paclitaxel as safe in Asian patients as it is in the overall population?Breast Cancer Research (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 13, 2017 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

' Intriguing': 9 Weeks of Trastuzumab for Breast Cancer'Intriguing': 9 Weeks of Trastuzumab for Breast Cancer
Nine weeks of therapy fell short of being noninferior to 12 months for the primary outcome, but overall survival was comparable, and the shorter course is less toxic and less expensive.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 8, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Pembro Boosts Treatment Impact in Advanced Breast Cancer Pembro Boosts Treatment Impact in Advanced Breast Cancer
Adding pembrolizumab to trastuzumab in treatment-resistant advanced breast cancer appears to reactivate the immune response and achieve a clinical benefit, early-phase trial data suggest.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 7, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Trastuzumab No Benefit In Low-HER2 Breast Cancer (CME/CE)
(MedPage Today) -- New findings should ditch use of drug for women not clearly HER2-positive (Source: MedPage Today Surgery)
Source: MedPage Today Surgery - December 6, 2017 Category: Surgery Source Type: news

No Trastuzumab Benefit in HER2-Low Breast Cancer After All No Trastuzumab Benefit in HER2-Low Breast Cancer After All
Despite previous analyses suggesting that adding trastuzumab to adjuvant chemotherapy may benefit patients with low HER2 expression, a new large trial shows no impact on outcomes.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 6, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Ogivri (Trastuzumab-Dkst Injection, for Intravenous Use) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 6, 2017 Category: Drugs & Pharmacology Source Type: news

USFDA okays Mylan, Biocon's biosimilar of cancer drug Herceptin
Ogivri is the first USFDA approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
December 1, 2017 -- The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2017 Category: Drugs & Pharmacology Source Type: news

FDA OKs Mylan's biosimilar of Roche cancer drug Herceptin
(Reuters) - The U.S. Food and Drug Administration on Friday approved Mylan NV's biosimilar of Herceptin, Roche's blockbuster treatment for breast cancer, making it the second copycat drug for cancer approved in the United States. (Source: Reuters: Health)
Source: Reuters: Health - December 1, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Approves Biosimilar Trastuzumab for HER+ Breast Cancer FDA Approves Biosimilar Trastuzumab for HER+ Breast Cancer
The agency has approved the first biosimilar that corresponds to Herceptin for use in HER2+ breast and metastatic stomach cancer.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 1, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

FDA Approves Trastuzumab Biosimilar
(MedPage Today) -- Includes HER2-positive breast, stomach cancer (Source: MedPage Today Gastroenterology)
Source: MedPage Today Gastroenterology - December 1, 2017 Category: Gastroenterology Source Type: news

FDA approves Mylan's biosimilar of Roche's cancer drug Herceptin
(Reuters) - The U.S. Food and Drug Administration on Friday approved Mylan NV's biosimilar version of Roche's blockbuster breast cancer treatment Herceptin. (Source: Reuters: Health)
Source: Reuters: Health - December 1, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Ogivri, a biosimilar to the cancer drug Herceptin, is approved for HER2+ breast cancer and metastatic stomach cancers SILVER SPRING, Md., Dec. 1, 2017 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration today approved Ogiv... Biopharmaceuticals, Oncology, FDA Mylan, Ogivri, trastuzumab-dkst, breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 1, 2017 Category: Pharmaceuticals Source Type: news

FDA approves first biosimilar for the treatment of certain breast and stomach cancers
The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. (Source: World Pharma News)
Source: World Pharma News - December 1, 2017 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

What's Hot at SABCS 2017? What's Hot at SABCS 2017?
Can the duration of adjuvant therapy in breast cancer be reduced? Is trastuzumab effective in HER2-negative tumors? These are among the hot topics that will be discussed.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 28, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

An IIT solution to 'expensive' biotechnology
Trastuzumab, a drug developed through bio-engineering, currently has a maximum retail price of Rs 52,000-58,602 for a 440 mg vial, depending on the brand, according to the National Pharmaceutical Pricing Authority. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 20, 2017 Category: Pharmaceuticals Source Type: news

Trastuzumab Use, on Its Own, Should Not Delay Post-surgical Breast Reconstruction Trastuzumab Use, on Its Own, Should Not Delay Post-surgical Breast Reconstruction
Breast reconstruction after cancer surgery doesn't need to be delayed if the patient is taking trastuzumab, new research suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 17, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Trastuzumab treatment need not delay breast reconstruction following mastectomy
(American College of Surgeons) Treatment with trastuzumab (Herceptin/Genentech) of breast cancers that express the HER-2 protein does not increase the risk for complications at the surgical site for women who undergo immediate breast reconstruction after mastectomy. The first study to assess the effect of trastuzumab on surgical wound complications indicates that breast reconstruction need not be delayed because of the type or length of this form of adjuvant therapy. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 3, 2017 Category: International Medicine & Public Health Source Type: news

Roche's Perjeta regimen gets FDA priority review in breast cancer
ZURICH (Reuters) - The U.S. Food and Drug Administration (FDA) has granted priority review for Roche's Perjeta in combination with Herceptin and chemotherapy for treating HER2-positive early breast cancer after surgery, Roche said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - September 29, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA grants Priority Review for Roche ’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
Roche today announced the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC). The FDA is exp ected to make a decision on approval by 28 January 2018. (Source: Roche Media News)
Source: Roche Media News - September 29, 2017 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review for Roche ’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
Roche today announced the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC). The FDA is exp ected to make a decision on approval by 28 January 2018. (Source: Roche Investor Update)
Source: Roche Investor Update - September 29, 2017 Category: Pharmaceuticals 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

Breast cancer biosimilar approval delayed as US FDA reviews additional information by Biocon, Mylan
Biocon and Mylan have together developed the trastuzumab biosimilar, which is a copy of a complex biologic drug developed by Swiss biotech giant Roche. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 30, 2017 Category: Pharmaceuticals 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

Case Closed on < 1 Year of Herceptin for Breast Cancer Case Closed on < 1 Year of Herceptin for Breast Cancer
For early-stage breast cancer, the treatment duration of 1 year for trastuzumab was a guess. New research indicates it was a good guess.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 25, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Case Closed on < 1 Year of Trastuzumab for Breast Cancer Case Closed on < 1 Year of Trastuzumab for Breast Cancer
For early-stage breast cancer, the treatment duration of 1 year for trastuzumab was a guess. New research indicates it was a good guess.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 25, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Biocon pulls application for EU approval of two drugs
Biocon will re-submit the applications for breast cancer drug Trastuzumab and Pegfilgrastim, which cuts infection risk in patients undergoing chemotherapy. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 16, 2017 Category: Pharmaceuticals Source Type: news

Trastuzumab for six months cost  effective in Iran
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - August 1, 2017 Category: Drugs & Pharmacology 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

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

Roche, Emcure may end pact to make 2 blockbuster drugs
Emcure is still the distributor for those two drugs in India. Roche had handed out the manufacturing and marketing of trastuzumab and rituximab to Pune-based Emcure. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 24, 2017 Category: Pharmaceuticals 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

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

Biosimilars to Avastin and Herceptin Head for US Market Biosimilars to Avastin and Herceptin Head for US Market
Two new biosimilars, bevacizumab and trastuzumab, were unanimously recommended for approval by an FDA oncologic advisory committee.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 14, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Biosimilars Get Clean Sweep at FDA Hearings
(MedPage Today) -- Unanimous backing for Herceptin biosimilar; follows identical vote for Avastin copy (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - July 13, 2017 Category: American Health 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

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

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

In a world ruled by rumour, it is vital that scientists speak with humility and clarity | Sue Desmond-Hellmann
Facts are the science world ’s stock-in-trade, but in an era of fake news it is ever more important to build public trust by avoiding exaggerated claims and jargonOne of my most cherished possessions is a handmade cherrywood salad bowl that ’s never held a leaf of lettuce. It is 25 years old and gets more beautiful every year. The bowl was a gift, carved by a widower who was left to raise his daughter alone when his wife died under my care as an oncologist. My patient, who I’ll call Erica, had the most challenging form of breast ca ncer and I didn’t have the tools to save her life. I’ve always...
Source: Guardian Unlimited Science - June 23, 2017 Category: Science Authors: Sue Desmond-Hellmann Tags: Global development Science Science and scepticism World news Climate change Source Type: news

UC consortium formed to speed up development of new drugs
For 12 years, UCLA researcher Dennis Slamon pursued a groundbreaking approach to treating breast cancer: Attack the disease genetically.The journey was long and filled with obstacles, but his persistence paid off.Slamon and colleagues conducted laboratory and clinical research that, in collaboration with biotechnology firm Genentech, helped lead to development of the breast cancer drug Herceptin.UCLA's Dennis Slamon with Harry Connick Jr., who played the professor of medicine in a 2008 television movie.The drug, which targets a specific genetic alteration found in about 25 percent of breast cancer patients, has saved thous...
Source: UCLA Newsroom: Health Sciences - June 21, 2017 Category: Universities & Medical Training Source Type: news