FDA clears AstraZeneca's Lumoxiti for certain patients with relapsed or refractory hairy cell leukaemia

AstraZeneca on Thursday announced that the FDA approved Lumoxiti (moxetumomab pasudotox-tdfk) for use in adults with relapsed or refractory hairy cell leukaemia who have received at least two prior therapies, including a purine nucleoside analogue. Dave Fredrickson, executive vice president of the global head oncology business unit, commented "this approval provides the first FDA-approved medicine for this condition in more than 20 years."  

Approval of the drug was backed by safety and efficacy data from a single-arm clinical trial involving 80 patients with previously treated hairy cell leukaemia. In the study, the results of which were unveiled in June, Lumoxiti was linked to an overall response rate of 75 percent, including a complete response rate of 41 percent, as well as a durable response rate of 30 percent.  

The FDA granted priority review to AstraZeneca's submission of the therapy in April, while the drug was also granted breakthrough therapy and orphan drug status. 

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