Policy & Regulation
ODAC to assess Talon's Marqibo on 21 March
3 February 2012 - US Talon Therapeutics Inc (OTCBB:TLON) said today that the Oncologic Drug Advisory Committee (ODAC) is scheduled to evaluate Marqibo (vincristine sulfate liposomes injection) on 21 March 2012.

The PDUFA date for the company's New Drug Application (NDA) is 13 May 2012.

Talon's NDA for Marqibo was accepted for filing by the US Food and Drug Administration (FDA) and is being reviewed under Subpart H - Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses, for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy.
Login
Username:

Password: