RE:FDA issues Complete Response Letter to ADC biotech developerRepost on FDA decision to suspend Byondis' anti-body drug conjugate (ADC) approvability.
May 15, 2023 - According to the complete response letter, the FDA suspends the decision on the Byondis' antibody drug conjugate (ADC) approvability.
Byondis sought approval for its anti-HER2 antibody-drug conjugate (ADC) in HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), a disease with a high unmet medical need.
ADC's are the main focus of Pfizer's US$43 Billion aquisition of Seagen.