The safety profile of Marqibo is predictable, manageable, and similar to
vincristine sulfate. Adverse events occurring in greater than 30 percent of subjects include neuropathy, nausea, constipation, pyrexia, decreased appetite, and febrile neutropenia.
Biocristin (a) (
Vincristine sulfate) @ 0.025 mg/kg iV in 50 ml normal saline, inj.
The company said that the clinical studies supports a favourable benefit/risk assessment for use of Marqibo (
vincristine sulfate liposomes injection) 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.
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.
Upon FDA approval, orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Marqibo(r) (
vincristine sulfate injection, OPTISOME(tm)) in the treatment of adult patients with metastatic uveal melanoma.
Talon will use the raised amount to back its efforts to secure approval from the US Food and Drug Administration (FDA) for its cancer drug Marqibo (
vincristine sulfate liposomes injection).