Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe
Byondis has filed for clearance of its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the United States and Europe, setting up a battle with heavyweight competitors Roche and AstraZeneca/Daiichi Sankyo next year. The Dutch company submitted the ADC to the FDA last week, and yesterday, the company said that the EMA had formally begun its review of the drug for HER2-positive, locally advanced or metastatic breast cancer that cannot be treated surgically. Byondis believes trastuzumab duocarmazine (SYD985) is a "next-generation" anti-HE...
