NICE does not recommend tucatinib for advanced breast cancer
NICE has published draft guidance for public consultation which does not recommend tucatinib (also called TUKYSA and made by Seagen Inc), in combination with trastuzumab and capecitabine, for some types of breast cancer that has spread. (Source: NHS Networks)
Source: NHS Networks - October 27, 2021 Category: UK Health Source Type: news

Better Way to Fight Breast Cancer That Has Spread to Brain
Scientists are reporting a first: They used an advanced ultrasound technique to help deliver the drug Herceptin to the patients' brain tumors. (Source: WebMD Health)
Source: WebMD Health - October 18, 2021 Category: Consumer Health News Source Type: news

Ultrasound trial offers hope for brain cancer patients
New technique temporarily allows drugs to cross blood brain barrier to treat tumoursA technique has been developed that could revolutionise thetreatment of brain cancers and neurodegenerative diseases by temporarily allowing drugs and other substances to cross the blood brain barrier – a structure that separates the brain’s blood vessels from the rest of its tissues.A trial in four women whose breast cancer had spread to the brain showed that magnetic resonance-guided focused ultrasound (MRgFUS) could safely deliver the antibody therapy Herceptin into their brain tissue, causing the tumours to shrink.Continue r...
Source: Guardian Unlimited Science - October 13, 2021 Category: Science Authors: Linda Geddes Tags: Medical research Neuroscience Breast cancer Alzheimer's Health Society Source Type: news

Breakthroughs in Metastatic Breast Cancer From ESMO 2021 Breakthroughs in Metastatic Breast Cancer From ESMO 2021
Dr Javier Cortes presents practice-changing data on metastatic breast cancer from ESMO 2021, including trastuzumab deruxtecan in HER2+ disease, pembrolizumab in TNBC, and ribociclib in HR+/HER2- disease.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 8, 2021 Category: Consumer Health News Tags: None ReCAP Source Type: news

Trastuzumab Deruxtecan Slows Metastatic Breast Cancer
Progression - free survival longer with T - DXd versus T - DM1 for HER2+ metastatic breast cancer previously treated with trastuzumab and taxane (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - September 24, 2021 Category: Cancer & Oncology Tags: Gynecology, Oncology, Pharmacy, Conference News, Source Type: news

' Astonishing' PFS Improvement in Metastatic HER+ Breast Cancer'Astonishing' PFS Improvement in Metastatic HER+ Breast Cancer
Experts hail the"astonishing" improvement in progression-free survival reported with trastuzumab deruxtecan in HER2+ metastatic breast cancer.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - September 22, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Six Months of Trastuzumab Effective in HER2+ Breast Cancer Six Months of Trastuzumab Effective in HER2+ Breast Cancer
A large-scale data analysis has confirmed that 6 months of trastuzumab is just as effective as 12 months in HER2+ early breast cancer, but the question is whether it will be adopted, say experts.Medscape News UK (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - September 20, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

' Smart Bomb' Salvage in HER+ Metastatic CRC'Smart Bomb' Salvage in HER+ Metastatic CRC
The higher the HER2 expression, the more benefit patients get from the antibody-drug conjugate trastuzumab deruxtecan for HER2-positive mCRC in the salvage setting, according to a phase 2 report.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 7, 2021 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Zydus Cadila launches breast cancer treatment drug Ujvira
"In a step that can significantly reduce treatment cost by almost 80 per cent, the drug is being offered at Rs 32,495 for a 100 mg vial. The current MRP of existing Trastuzumab Emtansine drug is Rs 1,59,225 for 100 mg vial. Ujvira will be available in two strengths, 100 mg and 160 mg," the company added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 24, 2021 Category: Pharmaceuticals Source Type: news

BERENICE: Further Evidence of Heart Safety of Dual HER2 Blockade BERENICE: Further Evidence of Heart Safety of Dual HER2 Blockade
Final results were presented at ESMO Breast Cancer 2021 on dual HER2 blockade with pertuzumab and trastuzumab on top of anthracycline-based neoadjuvant chemotherapy for early-stage breast cancer.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - May 14, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Study finds mechanism leading to herceptin resistance and Rx approach to reverse it
(Louisiana State University Health Sciences Center) Research conducted by an international team of scientists discovered a mechanism that leads to Herceptin resistance, representing a significant clinical obstacle to successfully treating HER2-positive breast cancer. They also identified a new approach to potentially overcome it. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 13, 2021 Category: International Medicine & Public Health Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
KENILWORTH, N.J.--(BUSINESS WIRE) May 5, 2021-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 5, 2021 Category: Drugs & Pharmacology Source Type: news

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine ap...
Source: Roche Investor Update - April 27, 2021 Category: Pharmaceuticals Source Type: news

US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine ap...
Source: Roche Media News - April 27, 2021 Category: Pharmaceuticals Source Type: news

Biocon partners with Libbs Farmaceutica to launch generic drugs in Brazil
This partnership, which marks the entry of Biocon ’s generic formulations into Latin America, builds upon a successful association with Libbs, which began in 2017 to launch biosimilar Trastuzumab in Brazil. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 29, 2021 Category: Pharmaceuticals Source Type: news

Jos é Baselga, Who Advanced Breast Cancer Treatments, Dies at 61
He was a top executive at Memorial Sloan Kettering before resigning over payments from health care companies. He went on to lead cancer research at AstraZeneca. (Source: NYT Health)
Source: NYT Health - March 26, 2021 Category: Consumer Health News Authors: Katie Thomas Tags: Baselga, Jose Deaths (Obituaries) Cancer Breast Cancer Drugs (Pharmaceuticals) Research Herceptin (Drug) Conflicts of Interest AstraZeneca PLC Memorial Sloan-Kettering Cancer Center Source Type: news

FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)
Enhertu (fam-trastuzumab deruxtecan-nxki) for locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma and received a prior trastuzumab-based regimen. Combination of Opdivo (nivolumab) + Cabometyx (cabozantinib) as first-line treatment for advanced renal cell carcinoma (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer
TOKYO& MUNICH& BASKING RIDGE, N.J.--(BUSINESS WIRE) January 15, 2021 -- Daiichi Sankyo Company, Ltd.  (hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 15, 2021 Category: Drugs & Pharmacology Source Type: news

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

European Commission approves Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer
Basel, 23 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer.“This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The innovation of Phesgo...
Source: Roche Media News - December 23, 2020 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer
Basel, 23 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer.“This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The innovation of Phesgo...
Source: Roche Investor Update - December 23, 2020 Category: Pharmaceuticals Source Type: news

Margetuximab Approved for HER2+ Metastatic Breast Cancer Margetuximab Approved for HER2+ Metastatic Breast Cancer
A new monoclonal antibody targeting HER2 in breast cancer, margetuximab-cmkb, has shown superiority over trastuzumab in improving progression-free survival in heavily pretreated women.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 18, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

Combo HER2 Product Recommended for Approval in EU Combo HER2 Product Recommended for Approval in EU
The combination of pertuzumab and trastuzumab with hyaluronidase (Phesgo) for subcutaneous injection is coming soon to Europe.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 16, 2020 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

CHMP recommends EU approval of Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
Basel, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, adm inistered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European...
Source: Roche Media News - November 13, 2020 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
Basel, 13 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, adm inistered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European...
Source: Roche Investor Update - November 13, 2020 Category: Pharmaceuticals Source Type: news

Enhertu (fam-trastuzumab deruxtecan-nxki)
Title: Enhertu (fam-trastuzumab deruxtecan-nxki)Category: MedicationsCreated: 11/9/2020 12:00:00 AMLast Editorial Review: 11/9/2020 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - November 9, 2020 Category: Cancer & Oncology Source Type: news

Kadcyla (ado-trastuzumab emtansine)
Title: Kadcyla (ado-trastuzumab emtansine)Category: MedicationsCreated: 10/14/2020 12:00:00 AMLast Editorial Review: 10/14/2020 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - October 14, 2020 Category: Cancer & Oncology Source Type: news

HER2+ breast cancer patients live longer if drugs given before surgery eradicate tumour
(European Organisation for Research and Treatment of Cancer) Final analysis of results from a randomised clinical trial of lapatinib and trastuzumab given before surgery in patients with early HER2-positive breast cancer has found that women who had no signs of residual disease after treatment survived longer without the cancer returning than patients who did not. This was more likely to happen in patients who received the two anti-cancer drugs together, rather than as single agents. The research is presented at the 12th European Breast Cancer Conference. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 1, 2020 Category: Cancer & Oncology Source Type: news

Opening an autophagy window as the apoptosis door starts to close
(Tokyo Medical and Dental University) Tokyo Medical and Dental University (TMDU) researchers have successfully attached the cancer cell-targeting antibody Trastuzumab to a previously reported supermolecule that induces autophagic cell death. The antibody-drug conjugate (ADC) selectively targeted HER2-overexpressing cancer calls and reduced cell viability at lower concentrations than free supermolecule drug. It is hoped that the ADC will provide a targeted autophagic death route for treating apoptosis resistant cancer cells in vivo, and ultimately provide an alternate approach in the clinic. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - September 24, 2020 Category: Biology Source Type: news

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to re...
Source: Roche Media News - September 17, 2020 Category: Pharmaceuticals Source Type: news

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020
Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq® (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek® STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to re...
Source: Roche Investor Update - September 17, 2020 Category: Pharmaceuticals Source Type: news

Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 16, 2020 Category: Drugs & Pharmacology Source Type: news

Enhertu (Fam-trastuzumab Deruxtecan-nxki for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 8, 2020 Category: Drugs & Pharmacology Source Type: news

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoi...
Source: Roche Investor Update - August 6, 2020 Category: Pharmaceuticals Source Type: news

Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer
Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-fr ee survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoi...
Source: Roche Media News - August 6, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabl...
Source: Roche Investor Update - July 29, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabl...
Source: Roche Media News - July 29, 2020 Category: Pharmaceuticals Source Type: news

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
             Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine ’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered ...
Source: Roche Media News - July 14, 2020 Category: Pharmaceuticals Source Type: news

Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 13, 2020 Category: Drugs & Pharmacology Source Type: news

Trastuzumab cost effective in HER2-positive metastatic gastric cancer
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - June 30, 2020 Category: Drugs & Pharmacology Source Type: news

Genentech wins FDA OK for at-home combo of 2 marquee cancer drugs
Genentech Inc. won regulatory approval Monday of a breast cancer treatment that combines Herceptin and Perjeta with an enzyme and can be administered at home. The drug, branded as Phego, is the first time South San Francisco-based Genentech has combined two monoclonal antibodies that can be administered by a single injection just under the skin in combination with intravenous chemotherapy. With the enzyme hyaluronidase, it was approved for treatment of early and metastatic HER2-positive breast cancer. Genentech… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 29, 2020 Category: Biotechnology Authors: Ron Leuty Source Type: news

Genentech wins FDA OK for at-home combo of 2 marquee cancer drugs
Genentech Inc. won regulatory approval Monday of a breast cancer treatment that combines Herceptin and Perjeta with an enzyme and can be administered at home. The drug, branded as Phesgo, is the first time South San Francisco-based Genentech has combined two monoclonal antibodies that can be administered by a single injection just under the skin in combination with intravenous chemotherapy. With the enzyme hyaluronidase, it was approved for treatment of early and metastatic HER2-positive breast… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 29, 2020 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer
South San Francisco, CA -- June 29, 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 approved Phesgo, a fixed-dose combination (FDC) of Perjeta®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2020 Category: Drugs & Pharmacology Source Type: news

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer
Hematology / Oncology Approval (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
             Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo ™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC i...
Source: Roche Media News - June 29, 2020 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer
             Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo ™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC i...
Source: Roche Investor Update - June 29, 2020 Category: Pharmaceuticals Source Type: news

Yale Cancer Center study validates combination therapy for aggressive endometrial cancer
(Yale University) Yale Cancer Center (YCC) scientists have found that combining the targeted drug trastuzumab with chemotherapy significantly improves survival rates for women with a rare, aggressive form of endometrial cancer. These results may help to change the standard of care worldwide for the disease. The findings are published today in the journal Clinical Cancer Research. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - June 29, 2020 Category: Cancer & Oncology Source Type: news

Roche ’s Tecentriq in combination with chemotherapy (including Abraxane) meets primary endpoint of improved pathological complete response, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer
Basel, 18 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpassion031 study, evaluating Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chem otherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.“Tripl...
Source: Roche Media News - June 18, 2020 Category: Pharmaceuticals Source Type: news

Roche Pharma India expands partnership with Cipla for key oncology medicines
Roche Pharma India has signed a "distribution agreement with Cipla to expand the scope of the partnership to include, marketing and distribution of its trademark oncology drugs - trastuzumab (Herclon), bevacizumab (Avastin) and rituximab (Ristova) in India," the company said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 17, 2020 Category: Pharmaceuticals Source Type: news