US FDA approves Talon's Marqibo for rare leukemia
Last Updated: 2012-08-09 17:30:06 -0400 (Reuters Health)
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved Talon Therapeutics Inc's Marqibo treatment for adults with Philadelphia chromosome negative acute lymphoblastic leukemia.
Thursday's FDA approval is for acute lymphoblastic leukemia patients who have failed at least two other therapies.
The drug, a targeted version of generic chemotherapy drug vincristine, is injected once a week by a health care professional.
According to a statement from the FDA, the drug's effectiveness was evaluated in a single clinical trial in 65 adults whose leukemia had relapsed at least twice despite standard treatments, and who had at least one previous treatment response lasting at least 90 days. Ten patients (15.4%) responded with either a complete remission or a complete remission with incomplete blood count recovery. In those 10 patients, the median duration of documented remission was 28 days. The median time to the first event of relapse, death, or next therapy was 56 days.
In two single-arm safety trials of 83 patients, 76% had serious adverse events (e.g., low white blood cell counts with fever, hypotension, respiratory distress and cardiac arrest). The most common side effects included constipation, nausea, low blood cell counts, fever, nerve damage, fatigue, diarrhea, decreased appetite, and insomnia.
Marqibo will carry a Boxed Warning that the drug must be administered only intravenously because it is deadly if administered in other ways, such as into the spinal fluid, the FDA said.
The Boxed Warning also states that Marqibo has different dosage recommendations than vincristine sulfate injection alone.
The full announcement from the FDA is available here: http://1.usa.gov/MDg01R.
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