-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On August 11, the FDA granted accelerated approval for a new indication of Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki, DS-8201) for unresectable or metastatic HER2 mutation-positive adult non-small cell lung cancer who have previously received systemic therapy (NSCLC) patients
This is the first FDA-approved drug for HER2 mutation-positive non-small cell lung cancer
The FDA also approved Life Technologies' Oncomine™ Dx (tissue) kit and Guardant Health's Guardant360® CDx (plasma) kit as companion diagnostic tools for Enhertu
The FDA approval is based primarily on results from the multicenter, randomized, double-blind, dose-optimized DESTINY-Lung02 study
The median age of the 52 patients evaluated for efficacy was 58 years (30-78 years), and 69% were female; 79% were Asian, 12% were white, and 10% were other races
In terms of safety, the most common (≥20%) adverse reactions included abnormal laboratory parameters, nausea, decreased white blood cell count, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, decreased platelet count, decreased albumin, Increased aspartate aminotransferase, increased alanine aminotransferase, fatigue, constipation, decreased appetite, vomiting, increased alkaline phosphatase, hair loss
On August 5, the FDA just approved Enhertu 4 months ahead of schedule through Real Time Oncology Review (RTOR) and Project Orbis for the treatment of unresectable or metastatic HER2-low (HER2-low) breast cancer patients
