FDA approves leukaemia drug Marqibo
pharmafile | August 10, 2012 | News story | Sales and Marketing | FDA, Marqibo, Talon Therapeutics, lilly
The Food and Drug Administration has given the green light for Talon Therapeutics’ Marqibo to combat a rare form of leukaemia.
The US regulator has approved Marqibo (vincristine sulfate liposome injection) to treat adults with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukaemia (ALL).
The orphan drug, administered once a week, was pushed through under the FDA’s accelerated approval programme, which allows patients access to promising new drugs while companies conduct additional clinical studies.
ALL is a blood and bone marrow cancer which affects more than 6,000 men and women annually, of whom around 1,440 will die. The market for treatment is estimated at $100m.
It is not yet known whether Marqibo offers any improvement in overall survival, but it can now be given to patients who have had two or more relapses or whose disease has progressed following more than one anti-leukaemia therapy.
In a single trial to date, adults whose ALL had relapsed at least twice after standard treatments, and who had at least one previous treatment response lasting at least 90 days, were studied.
Around 15% of them had either a complete remission or a complete remission with incomplete blood count recovery: median remission was 28 days, with the median time to either the first relapse, death or next therapy was 56 days.
“We are delighted that Marqibo will be available to a patient population with an underserved heamatologic malignancy,” said Talon chief executive Steven Deitcher.
Getting the drug to market is the California-based company’s biggest success so far – the European Medicines Agency has also given the drug orphan status and a European submission is expected from Talon next year.
The drug’s safety has been evaluated in two single-arm trials of 83 patients – serious adverse events such as low white blood cell counts with fever, low blood pressure, respiratory distress and cardiac arrest occurred in 76% of patients.
In the US, a boxed warning will make clear that Marqibo can be deadly if not administered intravenously, and that it has different dosage recommendations to vincristine sulfate injection alone.
Vincristine, a microtubule inhibitor, was originally marketed under the brand name Oncovin by Lilly. It is FDA-approved for ALL and Non-Hodgkin’s Lymphoma, but Talon believes the Optisome technology used in Marqibo helps vincristine circulate in the blood for longer.
Adam Hill
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