Public healthcare company The US Food and Drug Administration Thursday authorised the marketing of Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL).

HCL is a rare, slow-growing cancer of the blood in which the bone marrow makes too many B cells (lymphocytes), a type of white blood cell that fights infection.

The US FDA has granted the approval of Lumoxiti to AstraZeneca Pharmaceuticals.

According to the company, Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use has been approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

In conjunction with the US FDA approval, the efficacy of Lumoxiti was studied in a single-arm, open-label clinical trial of 80 patients who had received prior treatment for HCL with at least two systemic therapies, including a purine nucleoside analog. About 30% of patients in the trial achieved durable CR (complete response) and the overall response rate (number of patients with partial or complete response to therapy) was 75%.