The course of intravenous injections with Lumoxiti (moxetumomab pasudotox-tdfk) is now available to the American public suffering from relapsed or refractory hairy cell leukemia (HCL).
Part of a new type of treatment called CD22-directed cytotoxin, the procedure is addressed to patients that have already received at least one previous systemic therapies, including those involving a purine nucleoside analog.
Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence said in the press release that “Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies”.
The clinical trial that supported this decision had 80 total participants, 63 male, and an average age of 60 years. Each one had undergone prior treatments unsuccessfully. They had administered 40 µg/kg of Lumoxiti intravenously on days 1, 3, and 5 of 28-day cycles, for up to 6 cycles.
About 30% of cases reached complete response (CR), defined as “maintenance of hematologic remission for more than 180 days”, and the overall response rate was about 75%.
As with most heavy forms of treatment, some adverse effects can be expected, most commonly swelling, nausea, fatigue, headache, fever, constipation, anemia and diarrhea.
Additional warnings can be seen on the box. These inform of the risk of developing capillary leak syndrome, with symptoms including difficulty breathing, weight gain, hypotension, or swelling of arms, legs and/or face.
The FDA also granted Fast Track and Priority Review designations to Lumoxiti, meaning the drug has significant potential in treating a serious condition and is to have a higher preference in evaluating the results.