Talon Therapeutics Inc. (TLON)’s blood- cancer treatment, Marqibo, won approval from U.S. regulators, giving the company its first marketed product.
The Food and Drug Administration cleared Talon’s medicine for adults with a form of acute lymphoblastic leukemia who have failed prior therapies, the South San Francisco, California- based company said today in a statement. Talon gained 1 percent to close at 98 cents in New York.
“Marqibo’s approval demonstrates the FDA’s commitment to the development and approval of drugs that address serious, unmet medical needs,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
While acute lymphoblastic leukemia is more commonly diagnosed in children, there will be an estimated 6,050 new cases in adults this year and 1,440 will die from the disease, according to the National Cancer Institute.
Marqibo was approved for adult patients with a rare type of the blood cancer that is negative for an abnormality known as the Philadelphia chromosome. This rare version affects about 1,400 adults in the U.S. a year, with fewer than 500 people failing two prior therapies, an FDA advisory panel said in its March report on Marqibo. The median survival time for patients who don’t respond to prior treatments is about three months.
Talon’s medicine is a liposomal formulation of vincristine sulfate, a drug first developed by Eli Lilly & Co. (LLY) in the 1960s based on a compound from the rosy periwinkle flower. Vincristine, known commercially as Oncovin, is used in combination with other drugs to treat non-Hodgkin’s lymphoma and acute lymphoblastic leukemia, though the side effects limit the amount that can be given to patients.
Talon’s product is a nanoparticle encapsulated form of vincristine and is designed to provide prolonged circulation of the chemotherapy in the blood and accumulation at the tumor site, the company said.
“This represents a transformational event for Talon and fulfillment of our most important corporate goal to date,” Chief Executive Officer Steven Deitcher said in the statement.
The company is considering selling the rights to Marqibo outside the U.S., among other deals, Deitcher said in a July 26 interview. He declined at that time to identify any of the potential buyers or partners. The company has access to $57 million in capital to market Marqibo, he said.
The FDA rejected Marqibo as a treatment for non-Hodgkin’s lymphoma in 2005 when it was being developed by Inex Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. (ENZN) Talon, formerly Hana Biosciences Inc., licensed Marqibo in 2006 from Inex.
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