FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer
On January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Seagen Announces FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
BOTHELL, Wash.--(BUSINESS WIRE) January 19, 2023 -- Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 19, 2023 Category: Drugs & Pharmacology Source Type: news
Wall Street Breakfast: The Week Ahead | Seeking Alpha
Economic releases dominate the calendar for the holiday-shortened week ahead. The Empire State Manufacturing Index will be released on January 18 to be followed by the produce price index report and retail sales report on January 19. The retail sales number for December is expected to be…#fairleadstrategies #silvergatecapital #netflix #pncfinancial #newyorkcity #berlin #brileysecurities #ohio #trastuzumab #monsterbeverage (Source: Reuters: Health)
Source: Reuters: Health - January 15, 2023 Category: Consumer Health News Source Type: news
T-DXd:'Remarkable' Survival Gains in Advanced Breast Cancer T-DXd:'Remarkable' Survival Gains in Advanced Breast Cancer
The antibody-drug conjugate trastuzumab deruxtecan continues to show impressive progression-free and overall survival gains in previously treated unresectable and/or metastatic HER2+ breast cancer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2022 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Phase III results show Roche's subcutaneous formulation of Tecentriq is comparable to intravenous Tecentriq and delivered in minutes
Administered under the skin, the subcutaneous formulation reduces time spent receiving treatment to approx. seven minutes, compared with 30-60 minutes for IV infusion1Roche has submitted data from the IMscin001 study to health authorities, seeking approval for the subcutaneous option across all approved indications of IVTecentriq If approved,Tecentriq would be Roche ’s fourth subcutaneous cancer therapy,2-4 helping to improve the treatment experience for patients. In addition, it could save resources for healthcare systems5-10Basel, 1 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new pivotal data ...
Source: Roche Investor Update - December 1, 2022 Category: Pharmaceuticals Source Type: news
Managing T-DXd Adverse Events in the Real World Managing T-DXd Adverse Events in the Real World
Managing adverse events with trastuzumab deruxtecan (Enhertu) in real-world clinical practice is proving trickier than would have been anticipated from clinical trial reports.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 25, 2022 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
What Role Now for Margetuximab in HER2 Breast Cancer? What Role Now for Margetuximab in HER2 Breast Cancer?
In the final report of a phase 3 trial, there was no overall survival advantage with margetuximab vs trastuzumab.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 14, 2022 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Group salesup 2%[1] at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye diseases)US approval...
Source: Roche Investor Update - October 18, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Basel, 18 October 2022Group salesup 2%1 at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye ...
Source: Roche Media News - October 18, 2022 Category: Pharmaceuticals Source Type: news
Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. These patients with HER2 low status may now be eligible for a targeted treatment, which could significantly improve their outcomes.1,2The PATHWAY anti-HER2 (4B5) test is the only FDA approved companion diagnostic indicated as an aid in the assessment of HER2 low status in metastatic breast cancer patients. These patients may now consider ENHERTU as a treatment option based on the results of the Phase 3 DESTINY-Breast04 trial.3Basel, 4 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug ...
Source: Roche Media News - October 4, 2022 Category: Pharmaceuticals Source Type: news
Risk for ILD/Pneumonitis Examined for Trastuzumab Deruxtecan
MONDAY, Aug. 22, 2022 -- For patients receiving trastuzumab deruxtecan (T-DXd) monotherapy, the incidence of adjudicated drug-related interstitial lung disease (ILD)/pneumonitis is 15.4 percent, according to a study published online Aug. 11 in ESMO... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 22, 2022 Category: Pharmaceuticals Source Type: news
Lung Adverse Effects in Patients Taking Trastuzumab Deruxtecan Lung Adverse Effects in Patients Taking Trastuzumab Deruxtecan
Cancer patients treated with the targeted agent need to be closely monitored for interstitial lung disease/pneumonitis as an adverse event, say researchers reporting a new analysis.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - August 18, 2022 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
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
