Menarini Group ’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from 2L and 3L ER+/HER2- advanced or metastatic breast cancer
Submission supported by results from the pivotal... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2022 Category: Drugs & Pharmacology Source Type: news
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
MONDAY, Aug. 8, 2022 -- The U.S. Food and Drug Administration has approved Enhertu (am-trastuzumab-deruxtecan-nxki), an intravenous infusion treatment for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-low... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 8, 2022 Category: Pharmaceuticals Source Type: news
Enhertu Approved in the US as the First HER2-Directed Therapy for Patients with HER2-Low Metastatic Breast Cancer
Based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
6 August 2022 --... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2022 Category: Drugs & Pharmacology Source Type: news
FDA Okays First Targeted Agent for HER2-Low Breast Cancer FDA Okays First Targeted Agent for HER2-Low Breast Cancer
The targeted therapy led to longer progression-free and overall survival compared with chemotherapy.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 5, 2022 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news
FDA OKs First Targeted Drug for HER2-Low Breast Cancer
(MedPage Today) -- The FDA has approved the first targeted therapy for unresectable/metastatic breast cancer in the newly defined low-HER2 subtype.
The approval for trastuzumab deruxtecan (T-DXd, Enhertu) recognizes the recent expansion of the... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - August 5, 2022 Category: American Health Source Type: news
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 5, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Roche ’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results
IMscin001 study showed non-inferior levels of cancer immunotherapyTecentriq in the blood, when injected subcutaneously, compared to intravenous infusion, in people with advanced non-small cell lung cancerAdministered under the skin, the subcutaneous formulation reduces time spent receiving treatment to just minutes, compared with up to an hour for IV infusionData will be submitted to health authorities globally, including the US Food and Drug Administration and European Medicines AgencyBasel, 2 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMscin001 study evaluating a subcutaneous form...
Source: Roche Media News - August 2, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follicular lymphoma) andT...
Source: Roche Investor Update - July 21, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Basel, 21 July 2022Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follic...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news
Eight-year data from APHINITY study show Roche ’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer
Discussion on the Optimal Primary Breast Cancer Treatment. Breast Care 2019;14:103-10.[11] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited June 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf.[12] European Medicines Agency. Phesgo. [Internet; cited June 2022]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo.[13] World Health Organization. Cancer. [Internet; cited June 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.[14] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (H...
Source: Roche Media News - July 14, 2022 Category: Pharmaceuticals Source Type: news
FDA Accepts Byondis ’ Biologics License Application for [Vic-]Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer
12 July 2022 -- Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, announced today that the U.S. Food& Drug Administration (FDA) accepted the company’s submission of a Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 12, 2022 Category: Drugs & Pharmacology Source Type: news
What Is HR and HER2 Breast Cancer?
Title: What Is HR and HER2 Breast Cancer?Category: Diseases and ConditionsCreated: 7/7/2022 12:00:00 AMLast Editorial Review: 7/7/2022 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - July 7, 2022 Category: Cancer & Oncology Source Type: news
Highlights in Early Breast Cancer From ASCO 2022 Highlights in Early Breast Cancer From ASCO 2022
Highlights in early breast cancer from ASCO 2022 include results from NeoSTAR in triple-negative disease and 8-year follow-up of the ASTRRA study in ER+/HER2- patients, as reported by Dr Ann Partridge.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 5, 2022 Category: Consumer Health News Tags: None ReCAP Source Type: news
Facebook Ads Tout Unproven Therapy; Younger People Skip CRC Tests; Low-HER2 Tumors
(MedPage Today) -- Despite vowing to combat medical misinformation, Facebook continues to accept ads for unproven cancer treatments. (MIT Technology Review)
A federal judge denied a request by Bristol Myers Squibb (BMS) to dismiss a $6.4 billion... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - July 1, 2022 Category: Hematology Source Type: news
ASCO 2022: Immediate Options for Endocrine Therapy-Refractory Patients With HER2-Low Metastatic Breast Cancer ASCO 2022: Immediate Options for Endocrine Therapy-Refractory Patients With HER2-Low Metastatic Breast Cancer
Tarah J. Ballinger, MD, discusses the implications of the DESTINY-Breast 04 trial and the immediate impact that it will have on the lives of her patients.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 23, 2022 Category: Consumer Health News Tags: None MDAngle Source Type: news
