APHINITY study shows Roche ’s Perjeta-based regimen reduced the risk of invasive cancer returning compared to Herceptin and chemotherapy in HER2-positive early breast cancer
Roche, the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) today announced the Phase III APHINITY study showed adjuvant (after surgery) treatment with the combination of Perjeta ® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) significantly reduced the risk of breast cancer recurrence or death (invasive disease-free survival; iDFS) by 19% in people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alon e (HR=0.81; 95% CI 0.66-1.00, p=0.045). (Source: Roche Investor Update)
Source: Roche Investor Update - June 5, 2017 Category: Pharmaceuticals Source Type: news

Adding a second HER2 blocker may lower chance of invasive breast cancer for some women
(American Society of Clinical Oncology) A phase III clinical trial of 4,805 women with HER2-positive breast cancer suggests adding a second HER2 targeted medicine, pertuzumab (Perjeta), to standard of care trastuzumab (Herceptin) after surgery may help, although the benefit is modest. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - June 5, 2017 Category: Cancer & Oncology Source Type: news

Biosimilar May Be As Effective as Trastuzumab for Early Breast Cancer (FREE)
By Kelly Young Edited by Susan Sadoughi, MD, and Andr é Sofair, MD, MPH Biosimilar trastuzumab appears to have a similar effect on HER2-positive, early-stage breast cancer as standard trastuzumab (Herceptin), according … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - June 5, 2017 Category: Primary Care Source Type: news

Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer
Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - May 25, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Herceptin (Trastuzumab) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 22, 2017 Category: Drugs & Pharmacology Source Type: news

Vinorelbine, Pertuzumab, and Trastuzumab for Breast Cancer Vinorelbine, Pertuzumab, and Trastuzumab for Breast Cancer
Is the combination of vinorelbine with dual HER2-targeted therapy a good first-line option for patients needing an alternative to docetaxel?Breast Cancer Research (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 27, 2017 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

RT Plus Trastuzumab Have Little Effect on LVEF in HER2+ Breast Cancer
Trastuzumab plus low-dose radiotherapy does not have a significant effect on left ventricular ejection fraction changes in HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - April 20, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer HER2-Positive Breast Cancer News Source Type: news

Dual HER2 Blockade Promising in HER2-Positive Metastatic CRC
Dual HER2 blockade with trastuzumab and lapatinib yielded good response rates in HER2-amplified, RAS wild type, treatment-refractory metastatic colorectal cancer patients, according to results of the HERACLES study. (Source: CancerNetwork)
Source: CancerNetwork - April 19, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Conferences/AACR 2017 Colorectal Cancer Gastrointestinal Cancer News Source Type: news

Dexrazoxane Adds Cardioprotective Effect in HER2-Positive Breast Cancer
Administration of dexrazoxane along with adjuvant chemotherapy was cardioprotective in patients with HER2-positive breast cancer treated with chemotherapy followed by 1 year of trastuzumab maintenance therapy. (Source: CancerNetwork)
Source: CancerNetwork - April 19, 2017 Category: Cancer & Oncology Authors: Dave Levitan Tags: Breast Cancer Cancer Complications HER2-Positive Breast Cancer News Source Type: news

Trastuzumab Disappoints in HER2-Positive Gastroesophageal Cancer Trastuzumab Disappoints in HER2-Positive Gastroesophageal Cancer
The HER2-targeted monoclonal antibody trastuzumab coupled with the tubulin inhibitor emtansine is no better than taxane against previously treated, HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 17, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Mylan Deal Clears Path for Biosimilar Copy of Roche's Herceptin Mylan Deal Clears Path for Biosimilar Copy of Roche's Herceptin
Generic drugmaker Mylan said on Monday it had reached a settlement with Roche providing"a clear pathway" for the launch of its biosimilar version of the Swiss company's top-selling breast cancer drug Herceptin in major markets.Reuters Health Information (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - March 14, 2017 Category: Pathology Tags: Hematology-Oncology News Source Type: news

Mylan Announces Global Settlement and License Agreements with Genentech and Roche on Herceptin(R)
HERTFORDSHIRE, England and PITTSBURGH, March 13, 2017 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that Mylan has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. ... Biopharmaceuticals, Oncology, Generics, Licensing Mylan, Genentech, Roche Group, Herceptin, trastuzumab, breast cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 13, 2017 Category: Pharmaceuticals Source Type: news

Mylan reaches deal with Herceptin
Mylan NV announced Monday a deal with Genentech Inc. and F. Hoffmann-La Roche Ltd. that will clear the way for Mylan to launch its version of a drug to treat breast cancer. Financial terms of the deal between Mylan (Nasdaq: MYL) and Genentech and F. Hoffmann-La Roche weren't announced, although Mylan will receive a global license to launch trastuzumab, the generic name for Herceptin. It also will withdraw challenges to patents by Genentech. The license deal does not include Mexico, Brazil or Japan,… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 13, 2017 Category: Pharmaceuticals Authors: Paul J. Gough 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

Phase III APHINITY study shows Roche's Perjeta ® regimen helped people with an aggressive type of early breast cancer live longer without their disease returning compared to Herceptin® and chemotherapy
Roche (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS) have announced positive results from the phase III APHINITY study. The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (Source: World Pharma News)
Source: World Pharma News - March 6, 2017 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

Roche reports positive results from Phase III trial of perjeta combination therapy in breast cancer
Roche has reported positive results from the Phase III (APHINITY) clinical trial of perjeta (pertuzumab) in combination with herceptin (trastuzumab) and chemotherapy for the treatment of patients with breast cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - March 3, 2017 Category: Pharmaceuticals Source Type: news

Roche Shares Boosted by Cancer Drug Trial Success
Roche shares rose sharply after the company reported a clinical trial success that could help cushion it against looming competition for Herceptin and boost sales for its newer Perjeta drug. (Source: WSJ.com: Health)
Source: WSJ.com: Health - March 2, 2017 Category: Pharmaceuticals Tags: FREE Source Type: news

Shorter herceptin breast cancer treatment may produce better results
(University College London) Breast cancer patients who receive the drug Herceptin for nine weeks as part of their post-surgery chemotherapy regime may enjoy better health outcomes, according to new research led by UCL, compared to those who receive it for 12 months, the period currently recommended in the English National Health Service. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - March 1, 2017 Category: Cancer & Oncology Source Type: news

Delhi HC asks government if it approved Biocon ’s trastuzumab for three cancers
Biosimilars are copies of complex drugs based on living cells. They are different from chemical-based generic drugs, which are 'identical' to the compound used in the original. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 22, 2017 Category: Pharmaceuticals Source Type: news

South Africa: TAC Calls for Roche to Drop Price of Cancer Drug
[GroundUp] Activists say that with generic competition trastuzumab could be R3,500 per course instead of the current price of over R200,000 (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 22, 2017 Category: African Health Source Type: news

Europe ready to embrace first copies of biotech cancer drugs
LONDON (Reuters) - Treatment with two important cancer drugs is about to get much cheaper in Europe with a cut-price copy of Roche's blood cancer drug Rituxan likely to hit the market imminently followed by a rival to its breast cancer medicine Herceptin. (Source: Reuters: Health)
Source: Reuters: Health - February 15, 2017 Category: Consumer Health News Tags: healthNews 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

Roche denies rumors it will shop diabetes unit, earnings
Roche (PINK:RHHBY) denied rumors that it was considering selling its diabetes unit today, saying that it is “committed” to the business. The company also predicted that competition and spending on new drugs would stall its margin growth in 2017, as patents expire for its blockbuster medications. The Swiss drugmaker’s 3 top-selling cancer drugs, Rituxan, Herceptin and Avastin, bring in annual revenue of more than 20 billion Swiss francs, Reuters reported, and they face incoming competition from biosimilar copies. The 1st copies of Rituxan and Herceptin could hit the European market later thi...
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes MassDevice Earnings Roundup Wall Street Beat Roche Roche Diabetes Care 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

US FDA accepts Mylan ’s BLA for proposed trastuzumab product
Biocon and Mylan have announced acceptance of the latter ’s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - January 13, 2017 Category: Pharmaceuticals Source Type: news

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 11, 2017 Category: Drugs & Pharmacology Source Type: news

Herceptin (trastuzumab)
Title: Herceptin (trastuzumab)Category: MedicationsCreated: 12/14/2000 12:00:00 AMLast Editorial Review: 1/5/2017 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - January 5, 2017 Category: Cancer & Oncology Source Type: news

Cambridge-based Merrimack halts cancer drug trial, spurring further stock slide
A bad year at Cambridge-based Merrimack Pharmaceuticals got worse on Wednesday when the company announced that it was halting a midstage trial of a breast cancer drug, sending its shares tumbling. Merrimack (Nasdaq: MACK) said it had decided to stop the Phase 2 study of MM-302, a treatment for metastatic breast cancer patients who have previously received three treatments developed by Genentech: Herceptin, Perjeta and Kadcyla. Progression-free survival — a key measure of how long a patie nt can… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 21, 2016 Category: American Health Authors: Max Stendahl 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

Protecting Hearts From Herceptin: MANTICORE Data'Unclear'Protecting Hearts From Herceptin: MANTICORE Data'Unclear '
Antihypertensive pharmacotherapy reduced chemo-mediated LVEF decline in patients with HER-2-positive early invasive breast cancer, but what does this mean?Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 13, 2016 Category: Consumer Health News Tags: Hematology-Oncology News 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

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

Proposed biosimilar drug shows potential as breast cancer treatment
(The JAMA Network Journals) Among women with metastatic breast cancer, treatment with a drug that is biosimilar to the breast cancer drug trastuzumab resulted in an equivalent overall response rate at 24 weeks compared with trastuzumab, according to a study published online by JAMA. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 1, 2016 Category: Cancer & Oncology Source Type: news

Pfizer's Herceptin biosimilar succeeds in key breast cancer study
(Reuters) - Pfizer Inc said on Wednesday its experimental biosimilar of Roche Holding AG's blockbuster breast cancer treatment Herceptin was found comparable with the branded version in a key study. (Source: Reuters: Health)
Source: Reuters: Health - November 30, 2016 Category: Consumer Health News Tags: healthNews 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

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

Mylan and Biocon make USFDA submission for proposed biosimilar trastuzumab
The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data that consists of two pharmacokinetic studies and a confirmatory efficacy and safety trial, Biocon stated in a release. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 8, 2016 Category: Pharmaceuticals 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

Critical illness drugs remain unaffordable
In fact, prices of certain drugs like trastuzumab are negotiated by patients with distributors, and hence available at a 25-30% discount to the government price. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 31, 2016 Category: Pharmaceuticals Source Type: news

Samsung BioLogics IPO Could Value Firm at $8.2 Billion
Samsung Group ’s biologic drug manufacturing arm announced fresh details on its plans for a November listing, the same day its subsidiary said it had sought European approval for a near-replica of top-selling cancer drug Herceptin. (Source: WSJ.com: Health)
Source: WSJ.com: Health - October 4, 2016 Category: Pharmaceuticals Tags: PAID Source Type: news

Samsung Bioepis seeks Europe approval for copy of Herceptin breast cancer drug
SEOUL (Reuters) - South Korea's Samsung Bioepis, a maker of cheaper copies of complex biotech drugs known as biosimilars, is seeking regulatory approval in Europe to sell its copy of Swiss giant Roche's blockbuster breast cancer drug Herceptin. (Source: Reuters: Health)
Source: Reuters: Health - October 4, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

EMA accepts Biocon and Mylan's regulatory submission for proposed breast cancer biosimilar drug
Biocon and Mylan are engaged in a court battle in India against Swiss biotech firm Roche over marketing restrictions imposed on their trastuzumab brands. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 25, 2016 Category: Pharmaceuticals Source Type: news

EMA accepts Mylan ’s MAA for proposed biosimilar trastuzumab for review
The European Medicines Agency (EMA) has accepted for review Mylan's marketing authorisation application (MAA) for a proposed biosimilar Trastuzumab, MYL-1401O, to treat certain human epidermal growth factor receptor 2 (HER2)-positive breast and gastr … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - August 24, 2016 Category: Pharmaceuticals Source Type: news

Excess Weight Linked to Cardiotoxicity in Breast Cancer (CME/CE)
(MedPage Today) -- Association seen whether anthracyclines were given alone or with trastuzumab (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - July 28, 2016 Category: Neurology Source Type: news

Updated testing guidelines make more women eligible for herceptin, yet benefit uncertain
Changes to HER2 testing guidelines for breast cancer in 2013 significantly increased the number of patients who test HER2-positive, according to a new study. Cancers that have an excess of HER2 protein or extra copies of the HER2 gene are called HER2-positive and can be treated with drugs like Herceptin that target HER2. HER2 stands for human epidermal growth factor receptor 2. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - July 27, 2016 Category: Science Source Type: news

Updated testing guidelines make more women eligible for herceptin, yet benefit uncertain
( Mayo Clinic ) Changes to HER2 testing guidelines for breast cancer in 2013 significantly increased the number of patients who test HER2-positive, according to a new study by Mayo Clinic researchers published in the Journal of Clinical Oncology. Cancers that have an excess of HER2 protein or extra copies of the HER2 gene are called HER2-positive and can be treated with drugs like Herceptin that target HER2. HER2 stands for human epidermal growth factor receptor 2. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - July 27, 2016 Category: Cancer & Oncology Source Type: news

Updated Testing Guidelines Make More Women Eligible for Herceptin, yet Benefit Uncertain
ROCHESTER, Minn. — Changes to HER2 testing guidelines for breast cancer in 2013 significantly increased the number of patients who test HER2-positive, according to a new study by Mayo Clinic researchers published in the Journal of Clinical Oncology. Cancers that have an excess of HER2 protein or extra copies of th e HER2 gene are called [...] (Source: Mayo Clinic Research News)
Source: Mayo Clinic Research News - July 26, 2016 Category: Research Source Type: news

Overweight, obesity increase risk of cardiotoxicity from anthracyclines
Being overweight or obese was significantly associated with a greater risk of developing cardiotoxicity among breast cancer patients treated with anthracyclines and/or trastuzumab, investigators... (Source: Family Practice News)
Source: Family Practice News - July 25, 2016 Category: Primary Care Source Type: news

Amgen, Allergan biosimilar found as effective as Roche cancer drug
(Reuters) - Amgen Inc and Allergan Plc said their copycat version of Roche Holding AG's blockbuster cancer treatment, Herceptin, was found as effective as the original in a late-stage study. (Source: Reuters: Health)
Source: Reuters: Health - July 21, 2016 Category: Consumer Health News Tags: healthNews Source Type: news