FDA Approves First Drug for HER2 Lung Cancer FDA Approves First Drug for HER2 Lung Cancer
The agency has granted an accelerated approval for trastuzumab deruxtecan (Enhertu) to be used in patients with metastatic non –small cell lung cancer whose tumors have HER2 mutations.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - August 12, 2022 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 11, 2022 Category: Drugs & Pharmacology Authors: FDA 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
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
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
Adding Opdivo in First-Line Shows Promise in HER2+ Esophagogastric Cancer
(MedPage Today) -- A combination of the PD-1 inhibitor nivolumab (Opdivo) plus trastuzumab and chemotherapy (mFOLFOX6) was effective as first-line therapy for patients with HER2 (ERBB2)-positive esophagogastric adenocarcinoma, according to results... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - June 23, 2022 Category: Hematology Source Type: news
Beta Blockers May Avert Cancer-Drug Cardiotoxicity Beta Blockers May Avert Cancer-Drug Cardiotoxicity
Treatment with some beta blockers may protect cardiac contractile function during anthracycline or trastuzumab therapy, suggests a meta-analysis that also confirmed such protection by dexrazoxane.First Look (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - June 14, 2022 Category: Cancer & Oncology Tags: Cardiology News Source Type: news
Enhertu Benefit in HER2-Low Breast Cancer:'Practice Changing'Enhertu Benefit in HER2-Low Breast Cancer:'Practice Changing '
Breast cancer patients with low levels of HER2 expression, previously considered untreatable with HER2-targeted therapies, had improved progression-free survival with trastuzumab deruxtecan (Enhertu).Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 6, 2022 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Trastuzumab Deruxtecan Ushers in New Treatment Era for HER2-Low Breast Cancer
(MedPage Today) -- CHICAGO -- Patients with HER2-low metastatic breast cancer treated with trastuzumab deruxtecan (Enhertu) achieved significant improvements in survival compared with those treated with chemotherapy alone, according to results... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - June 5, 2022 Category: Hematology Source Type: news
Data at the 2022 ASCO Annual Meeting highlight Roche ’s continued commitment to innovation in oncology and personalised healthcare
Pivotal data onglofitamab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with aggressive lymphoma, will be presented as part of our industry-leadinghaematology portfolioFurther studies exploring broad genomic testing to support informed treatment decisions for patients and advance cancer care approaches will be presentedBasel, 24 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncol...
Source: Roche Media News - May 24, 2022 Category: Pharmaceuticals Source Type: news
Data at the 2022 ASCO Annual Meeting highlight Roche ’s continued commitment to innovation in oncology and personalised healthcare
Pivotal data on glofitamab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with aggressive lymphoma, will be presented as part of our industry-leading haematology portfolioFurther studies exploring broad genomic testing to support informed treatment decisions for patients and advance cancer care approaches will be presentedBasel, 24 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Onc...
Source: Roche Media News - May 24, 2022 Category: Pharmaceuticals Source Type: news
