ARTICLE | Clinical News

Marqibo vincristine regulatory update

February 6, 2012 8:00 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on March 21 to discuss an NDA from Talon for Marqibo vincristine to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in patients with >=2 relapses or in patients whose cancer has progressed following >=2 leukemia therapies. The PDUFA date is May 13. The biotech is seeking accelerated approval based on data from the open-label Phase II rALLy study in 65 patients that showed an overall response rate of 35%, with 20% of patients achieving the primary endpoint of a complete remission (CR) or CR with incomplete hematologic recovery. ...