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 (pharmacokinet ics)...
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
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
Trazimera (Trastuzumab-qyyp) for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 10, 2020 Category: Drugs & Pharmacology Source Type: news
NCI-MATCH: T-DM1 shows promising activity in salivary gland cancer
(ECOG-ACRIN Cancer Research Group) A discovery from NCI-MATCH, the largest precision medicine cancer trial, relates to patients with salivary gland cancer treated with ado-trastuzumab emtansine (T-DM1), a drug already FDA-approved for certain types of breast cancer. Two of the three NCI-MATCH patients with this rare disease saw their tumors shrink by at least 30% with T-DM1 treatment and the benefit lasted two years for one patient and nine months for the other. Another recent trial reported similar benefits. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 7, 2020 Category: International Medicine & Public Health Source Type: news
Watchdog rejects use of genetic disorders drug in the NHS
NICE will not approve volanesorsen on the NHS Related items fromOnMedica NICE recommends Herceptin for gastric cancer H. pylori eradication linked to reduced risk of gastric cancer Use of DPP-4 inhibitors associated with increased risk of IBD Aspirin could also treat cancer, research suggests Antivirals cut liver cancer risk after hepatitis C (Source: OnMedica Latest News)
Source: OnMedica Latest News - January 5, 2020 Category: UK Health 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
Enhertu (Fam-trastuzumab Deruxtecan-nxki for Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 31, 2019 Category: Drugs & Pharmacology 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
Obesity is a risk factor for cardiotoxicity in chemotherapy-treated patients with breast cancer
(PLOS) A recent study showed that being overweight or obese was a risk factor for cardiotoxicity in chemotherapy-treated patients with breast cancer, but it did not take into account related cardiac risk factors or other classic risk factors of cardiotoxicity produced by anthracycline and trastuzumab. In a study published Dec. 23 in the open-access journal PLOS Medicine, Elis é Kabor é of Centre Georges-Fran ç ois Leclerc and Charles Guenancia of University Hospital, Dijon, France, and colleagues address this gap in knowledge. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 23, 2019 Category: Cancer & Oncology 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
