Brentuximab vedotin: Phase II data

Top-line data from a single-arm, open-label, international, pivotal Phase II trial in 102 patients who previously received an autologous stem cell transplant showed that brentuximab vedotin produced an ORR of 75%, with a median duration of response of >6 months. Based on the results, Seattle Genetics plans to submit a BLA to FDA in 1H11 seeking accelerated approval for brentuximab. The company also plans to submit an MAA in Europe next year. Patients received 1.8 mg/kg IV brentuximab every 3 weeks for up to 16 total doses. The company has an SPA from FDA for the trial. ...