FDA approves new drug for patients with metastatic breast cancer
The US Food and Drug Administration has approved the use of the drug tucatinib, or Tukysa, in combination with chemotherapy, for the treatment of adults with advanced forms of HER2-positive breast cancer that either cannot be removed with surgery, or has spread to other parts of the body, including the brain. (Source: CNN.com - Health)
Source: CNN.com - Health - April 18, 2020 Category: Consumer Health News Source Type: news

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
BOTHELL, Wash.--(BUSINESS WIRE) April 17, 2020 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in combination with trastuzumab and capecitabine... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves First New Drug With International Group FDA Approves First New Drug With International Group
The approval is for the oral therapy tucatinib (Tukysa, Seattle Genetics) for the treatment of advanced HER2-positive breast cancer.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 17, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

FDA Approves Tucatinib in Combination with Chemotherapy for HER2-Positive Breast Cancer
The FDA approved tucatinib in combination with chemotherapy for the treatment of adult patients with advanced forms of HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - April 17, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

Who Benefits from Herceptin and Other Anti-HER2 Cancer Therapies?
Calls to include a new breast cancer subtype in future clinical trials reveal fundamental disagreements about HER2's role in the disease. (Source: The Scientist)
Source: The Scientist - April 13, 2020 Category: Science Tags: News & Opinion Source Type: news

Indigenous American ancestry may be associated with HER2-positive breast cancer
(American Association for Cancer Research) An increased proportion of Indigenous American (IA) ancestry was associated with a greater incidence of HER2-positive breast cancer, according to a study published in Cancer Research, a journal of the American Association for Cancer Research. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 3, 2020 Category: International Medicine & Public Health Source Type: news

Data from Phase IIb AIPAC Trial of Eftilagimod Alpha Shows Promise
Immutep reported positive data from the randomized phase IIb AIPAC clinical trial of eftilagimod alpha and paclitaxel in HER2-negative, HR-positive metastatic breast cancer (MBC). (Source: CancerNetwork)
Source: CancerNetwork - April 1, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

Bevacizumab plus paclitaxel not cost effective for HER2 − MBC
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - March 31, 2020 Category: Drugs & Pharmacology Source Type: news

HER2-positive MBC has high short- and medium-term costs
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - March 31, 2020 Category: Drugs & Pharmacology Source Type: news

Trastuzumab Deruxtecan Shows Promise in HER2 Targeted Therapy
A study with a small sample size revealed that trastuzumab deruxtecan showed promising activity in multiple HER2-expressing or HER2-mutant solid tumors. (Source: CancerNetwork)
Source: CancerNetwork - March 27, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

Trastuzumab deruxtecan shows early promise in patients with non-breast/gastric cancers
(American Association for Cancer Research) A HER2-targeted antibody-drug conjugate, fam-trastuzumab deruxtecan-nxki (Enhertu), showed signs of clinical activity in multiple non-breast/non-gastric cancer types, according to results from a phase I study. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 25, 2020 Category: International Medicine & Public Health Source Type: news

Factors Associated with Lymph Node Involvement in T1 cT1N0 HER2-Positive Breast Cancer
This study sought to determine the patient and tumor characteristics associated with positive lymph nodes status in T1 HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - March 6, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

Analysis Reveals Ideal Time Period to Begin Adjuvant Chemotherapy for HER2-Positive Breast Cancer
The study found that 31 to 60 days seems to be the ideal time period to begin adjuvant chemotherapy in HER2-positive breast cancer patients. (Source: CancerNetwork)
Source: CancerNetwork - March 6, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

Individualizing Early-Stage HER2-Positive Breast Cancer
As more agents become approved, it ’s important to individualize therapy for this patient population, Sara A. Hurvitz, MD, said at the 37th Annual Miami Breast Cancer Conference. (Source: CancerNetwork)
Source: CancerNetwork - March 6, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer
FDA medical oncologists discuss the January 12, 2018, approval of olaparib, the first PARP inhibitor approved for the treatment of patients with metastatic breast cancer with a germline BRCA mutation. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 28, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, (Source: World Pharma News)
Source: World Pharma News - February 27, 2020 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer
LOS ANGELES, Calif., Feb. 26, 2020 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for neratinib in combination... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2020 Category: Drugs & Pharmacology Source Type: news

FDA approves neratinib for metastatic HER2-positive breast cancer
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves sNDA for Neratinib in Combination with Capecitabine for HER2+ Breast Cancer
The FDA approved a supplemental new drug application for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received at least 2 prior anti-HER2-based regimens in the metastatic setting. (Source: CancerNetwork)
Source: CancerNetwork - February 26, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subc utaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (phar...
Source: Roche Investor Update - February 25, 2020 Category: Pharmaceuticals Source Type: news

FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subc utaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (phar...
Source: Roche Media News - February 25, 2020 Category: Pharmaceuticals Source Type: news

FDA Accepts BLA for Fixed-Dose Subcutaneous Combination in HER2-Positive Breast Cancer
The FDA accepted a biologics license application for the fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with IV chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - February 25, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

FDA Accepts Genentech ’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer
South San Francisco, CA -- February 24, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 24, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Grants 2 Fast Track Designations for ALX148
The FDA granted 2 Fast Track designations for ALX148 for the first-line treatment of patients with head and neck squamous cell carcinoma, and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma. (Source: CancerNetwork)
Source: CancerNetwork - February 18, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news

FDA Grants Priority Review to Tucatinib for HER2-Positive Breast Cancer Treatment
The FDA granted a priority review to a new drug application submitted by Seattle Genetics, Inc. for tucatinib to treat patients with HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - February 14, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
BOTHELL, Wash.--(BUSINESS WIRE) February 13, 2020 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2020 Category: Drugs & Pharmacology Source Type: news

High BMI May Cut Overall Survival in HER2 + Metastatic Breast Cancer
BMI had no impact on progression - free survival to first - line chemotherapy (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - February 12, 2020 Category: Cancer & Oncology Tags: Gynecology, Oncology, Journal, Source Type: news

High BMI May Cut Overall Survival in HER2 & #43; Metastatic Breast Cancer
WEDNESDAY, Feb. 12, 2020 -- For patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (mBC) treated with pertuzumab and/or trastuzumab emtansine (T-DM1), a body mass index (BMI) of ≥30 kg/m² is... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 12, 2020 Category: Pharmaceuticals Source Type: news

Researchers uncover two-drug combo that halts the growth of cancer cells
(UT Southwestern Medical Center) UT Southwestern Simmons Cancer Center researchers have discovered a two-drug combo that halts the growth of cancer cells that carry HER2 mutations. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - January 23, 2020 Category: Cancer & Oncology Source Type: news

Breakthroughs in Metastatic Breast Cancer From SABCS 2019 Breakthroughs in Metastatic Breast Cancer From SABCS 2019
In metastatic breast cancer, top news at SABCS 2019 focused on two highly active drugs in HER2+ disease, an oral paclitaxel in TNBC, and evidence for a new standard front-line therapy in HR+ disease.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 8, 2020 Category: Consumer Health News Tags: None ReCAP Source Type: news

Africa: Hummingbird Bioscience Publishes Preclinical Data Demonstrating Efficacy of Hmbd-001 in Her3 Driven Cancers
[PR Newswire] Singapore -HER3 activation is implicated in tumor progression and in acquired resistance to EGFR and HER2 therapies (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - January 8, 2020 Category: African Health Source Type: news

T-DM1, Lapatinib, Nab-paclitaxel in HER2+ Breast Cancer T-DM1, Lapatinib, Nab-paclitaxel in HER2+ Breast Cancer
Should dual HER2 blockade plus nab-paclitaxel be considered for neoadjuvant treatment of HER2+ breast cancer?Breast Cancer Research (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 7, 2020 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

Early Breast Cancer Highlights From SABCS 2019 Early Breast Cancer Highlights From SABCS 2019
In early breast cancer, key points from SABCS include two major presentations in HER2+, benefit of preoperative pembrolizumab in TNBC, and CDK4/6 inhibition in the preoperative setting in HR+ disease.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 6, 2020 Category: Consumer Health News Tags: None ReCAP Source Type: news

Trastuzumab with Adjuvant Chemotherapy Reduces Risk of Relapse in HER2+ Breast Cancer
An analysis of the results of the phase III PANTHER trial showed that a combination of tailored dose-dense adjuvant chemotherapy and trastuzumab decreased the relative risk of relapse for patients with HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - January 3, 2020 Category: Cancer & Oncology Authors: Kevin Wright Source Type: news

Drug Trials Snapshot: ENHERTU
Treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Used in patients who have been previously treated for their metastatic disease with at least two anti-HER2 regimens. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

' Huge Year' for HER2+ Breast Cancer: Incorporating New Treatments'Huge Year' for HER2+ Breast Cancer: Incorporating New Treatments
Drs Kathy Miller and Sara Hurvitz reflect on some of the trial results, including HER2CLIMB and DESTINY-Breast01, presented at this year's SABCS that may'take your breath away. 'Medscape Oncology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 27, 2019 Category: Consumer Health News Tags: Hematology-Oncology Commentary Source Type: news

Maryland biotech seeks FDA approval for breast cancer treatment
MacroGenics Inc. (NASDAQ: MGNX) is closing in on the finish line to earn regulatory approval for its first product, a breast cancer therapy candidate. The Rockville biotech has submitted its Biologics License Application to the Food and Drug Administration for margetuximab, which targets “HER2” — a gene that can fuel cancer cell growth. FDA approval would give MacroGenics the final go-ahead to commercialize the product and treat patients w ith metastatic HER2-positive breast cancer along with… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 26, 2019 Category: Biotechnology Authors: Sara Gilgore Source Type: news

MacroGenics seeks FDA approval for breast cancer treatment
MacroGenics Inc. (NASDAQ: MGNX) is closing in on the finish line to earn regulatory approval for its first product, a breast cancer therapy candidate. The Rockville biotech has submitted its Biologics License Application to the Food and Drug Administration for margetuximab, which targets “HER2” — a gene that can fuel cancer cell growth. FDA approval would give MacroGenics the final go-ahead to commercialize the product and treat patients w ith metastatic HER2-positive breast cancer along with… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 24, 2019 Category: Biotechnology Authors: Sara Gilgore Source Type: news

MacroGenics seeks FDA approval for breast cancer treatment
MacroGenics Inc. (NASDAQ: MGNX) is closing in on the finish line to earn regulatory approval for its first product, a breast cancer therapy candidate. The Rockville biotech has submitted its Biologics License Application to the Food and Drug Administration for margetuximab, which targets “HER2” — a gene that can fuel cancer cell growth. FDA approval would give MacroGenics the final go-ahead to commercialize the product and treat patients w ith metastatic HER2-positive breast cancer along with… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 24, 2019 Category: Pharmaceuticals Authors: Sara Gilgore Source Type: news

Zoledronic Acid and Neoadjuvant Chemo in HER2- Breast Cancer Zoledronic Acid and Neoadjuvant Chemo in HER2- Breast Cancer
While adjuvant bisphosphonates are associated with longer survival in postmenopausal women with breast cancer, the same cannot be said for neoadjuvant bisphosphonates.Breast Cancer Research (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 24, 2019 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

Enhertu Approved for Unresectable, Metastatic HER2+ Breast Cancer
Title: Enhertu Approved for Unresectable, Metastatic HER2+ Breast CancerCategory: Health NewsCreated: 12/23/2019 12:00:00 AMLast Editorial Review: 12/24/2019 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - December 24, 2019 Category: Cancer & Oncology Source Type: news

Madelaine Kuiper, MSN, NP, Discusses Rapid Development of HER2-Targeted Therapies
The nurse practitioner from UCLA Health spoke about the expanding treatment options in this setting. (Source: CancerNetwork)
Source: CancerNetwork - December 24, 2019 Category: Cancer & Oncology Authors: Madelaine Kuiper, MSN, NP Source Type: news

Enhertu Approved for Unresectable, Metastatic HER2 + Breast Cancer
Treatment indicated for patients who have received at least two previous anti - HER2 - based regimens (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - December 24, 2019 Category: Cancer & Oncology Tags: Oncology, Pharmacy, FDA Approvals, Source Type: news

Enhertu Approved for Unresectable, Metastatic HER2 & #43; Breast Cancer
MONDAY, Dec. 23, 2019 -- Enhertu (fam-trastuzumab deruxtecan-nxki) has received accelerated approval for treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the U.S. Food and Drug... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 23, 2019 Category: General Medicine Source Type: news

New Cancer Medication Offers Hope For HER2-Positive Patients Who Failed Other Treatments
Enhertu was approved for the treatment of adults with HER2-positive breast cancer, that was either unable to be removed with surgery, had already spread to other parts of the both, or to patients who had received two or more treatments specific to HER2-positive breast cancer. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - December 23, 2019 Category: Pharmaceuticals Authors: Dana Dovey, Contributor Source Type: news

Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
BOTHELL, Wash.--(BUSINESS WIRE) December 23, 2019 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

FDA OKs New Antibody Drug Conjugate for HER2+ Breast Cancer FDA OKs New Antibody Drug Conjugate for HER2+ Breast Cancer
Trastuzumab deruxtecan is for the treatment of unresectable or metastatic HER2-positive breast cancer that has received two or more prior anti-HER2-based regimens in the metastatic setting.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 20, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer
The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (ENHERTU ®, Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
Today, the U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. (Source: World Pharma News)
Source: World Pharma News - December 20, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA Approves Trastuzumab Deruxtecan for HER2-Positive Breast Cancer
The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. (Source: CancerNetwork)
Source: CancerNetwork - December 20, 2019 Category: Cancer & Oncology Authors: Kristie L. Kahl Source Type: news