The FDA accepted a supplemental BLA and granted priority review for Seattle Genetics’ Hodgkin’s lymphoma drug Adcetris.
The agency based its decision on positive results from a phase 3 clinical trial to determine if the drug could extend progression-free survival in combination with chemotherapy. The PDUFA target action date for the drug is May 1.
The drug is currently being evaluated in more than 70 clinical trials. It is not currently approved as a frontline Hodgkin’s therapy.