FDA’dan lösemi ilacına onay… (İng)
Talon Therapeutics has gained FDA approval for Marqibo as a treatment for patients with Philadelphia chromosome negative acute lymphoblastic leukemia who do not respond to at least two prior therapies. Marqibo will be Talon’s first product on the market.
FDA approves Talon’s Marqibo for rare leukemia
WASHINGTON | Thu Aug 9, 2012 2:44pm EDT
(Reuters) – The Food and Drug Administration said on Thursday it has approved Talon Therapeutics Inc’s Marqibo treatment for adults with a rare form of leukemia known as Philadelphia chromosome negative acute lymphoblastic leukemia.
The drug, a targeted version of generic chemotherapy drug vincristine, will be the first commercial product for Talon.
The company is majority-owned by Warburg Pincus and Deerfield Management, but shares accounting for a minority portion of its equity trade over-the-counter and were down 5 percent in afternoon trading.
Talon licensed Marqibo in 2006 after the FDA turned down an application for the drug, filed by two other companies, as a treatment for relapsed non-Hodgkin’s lymphoma.
Thursday’s FDA approval is for acute lymphoblastic leukemia patients who have failed at least two other therapies.
Talon’s shares, which were down 5 percent at 92 cents, have more than doubled so far this year.