Talon pins its hopes on Marqibo FDA approval

Talon Therapeutics ($TLON) is pinning its hopes on an August approval for Marqibo, its encapsulated formulation of the anti-cancer drug Vincristine, according to an article in Reuters. Marqibo uses a liposomal technology known as Optisomes, designed to accumulate in cancer tissue and release the drug locally. This has potential to cut toxicity. Vincristine, first approved in 1963, is effective in cancer but can be pretty toxic to healthy tissues.

The submission is for the treatment of adults with a specific form of acute lymphoblastic leukemia (ALL), known as Philadelphia chromosome-negative, who have failed at least two other therapies. These are patients who have a poor prognosis and are running out of options. The company is also assessing the drug in newly diagnosed ALL patients and in aggressive lymphomas, and is in discussion with potential partners, as well as planning to create a sales force of its own.

Talon (previously known as Hana Biosciences) licensed Marqibo from Inex Pharmaceuticals in 2006, after it was turned down for the treatment of relapsed non-Hodgkin's lymphoma. In May, Talon's shares fell on the news that the FDA wanted more time to review the application, giving a now fast-approaching PDUFA date of Aug. 12. Since then it has won a vote of the FDA's Oncologic Drugs Advisory Committee (ODAC) at 7-4, a positive opinion for a drug for drastic cases but perhaps not a ringing endorsement.

"An approval of Marqibo more or less validates the technology," said Talon CEO Steven Deitcher in an interview with Reuters. "It opens up a broad spectrum of opportunities."

A lot is hanging on Aug. 12 for Talon and Marqibo. Watch this space.

- check out the article in Reuters

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