Lumoxiti FDA approval : AstraZeneca has bagged the US Food and Drug Administration (FDA) approval for its CD22-directed cytotoxin Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of relapsed or refractory hairy cell leukaemia (HCL).
Lumoxiti FDA approval for hairy cell leukaemia treatment is for adult patients who had undergone more than two systemic therapies in the past for their condition, including treatment with a purine nucleoside analog.
A rare, chronic, and slow-growing form of leukaemia, hairy cell leukaemia is characterized by the overproduction of abnormal B cell lymphocytes by the bone marrow. Hairy cell leukaemia can lead to serious, life-threatening conditions such as bleeding, infections and anaemia.
Commenting on Lumoxiti FDA approval for hairy cell leukaemia treatment, Dave Fredrickson – Executive Vice-President, Global Head Oncology Business Unit, AstraZeneca, said: “Today’s FDA approval of Lumoxiti represents a significant milestone for people living with hairy cell leukaemia, a rare blood cancer that can result in serious and life-threatening conditions. For patients, this approval provides the first FDA-approved medicine for this condition in more than 20 years.”
Lumoxiti’s recommended dose for hairy cell leukaemia treatment is 0.04 mg/kg, which is to be given as an intravenous infusion over 30 minutes on days 1, 3, and 5 of each 28-day cycle up to six cycles until the disease progresses or the toxicity levels become unacceptable.
Patients with severe renal impairment are not recommended to be treated with Lumoxiti, said AstraZeneca.
Lumoxiti FDA approval, which came under the FDA Priority Review, was driven by the results of the 1053 phase 3 single-arm trial which evaluated the hairy cell leukaemia drug as monotherapy in 80 patients who had been subjected to at least two prior therapies, including a purine nucleoside analog.
The primary endpoint of the trial was durable complete response (CR) which is maintenance of hematologic remission for over 180 days after achievement of CR.
As per the 1053 phase 3 trial, 30% of hairy cell leukaemia patients recorded durable CR while the overall response rate, that is number of patients with partial or complete response to Lumoxiti treatment, was 75%.
Richard Pazdur – director of the FDA’s Oncology Center of Excellence, Commenting on Lumoxiti FDA approval for hairy cell leukaemia treatment, said: “Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies.
“This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer.”
Recently, AstraZeneca and Amgen had been granted the FDA breakthrough therapy designation for their asthma drug tezepelumab.
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