FDA approves Asparlas for acute lymphoblastic leukemia
The FDA has approved calaspargase pegol-mknl for acute lymphoblastic leukaemia as part of a multiagent chemotherapeutic regimen for pediatric and young adult patients.
ALL is a cancer of the white blood cells and is characterized by an excess of lymphoblasts, an immature white blood cell. Lymphoblasts are normally found in the bone marrow but can be found in the blood and other locations in people with ALL. ALL accounts for about 75 per cent of childhood leukaemia in the U.S. and around 78 per cent in Europe; however, it can be a curable disease.
Approval was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when using calaspargase pegol-mknl, 2500 U/m2 intravenously, every 3 weeks. The pharmacokinetics of calaspargase pegol-mknl were studied when administered in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL.
Calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals) is an asparagine specific enzyme that is proven to have a longer interval between doses compared with other approved pegaspargase products. Cal-PEG would provide a treatment that has an extended shelf life beyond that of the current PEGylated asparaginase treatment, helping ensure availability to patients.
The corresponding study that supported the approval analyzed the drug with multiagent chemotherapy in 124 patients with B-cell lineage ALL.
The approval also was based on the drug’s achievement and maintenance of nadir serum asparaginase activity above 0.1 U/mL when using calaspargase pegol-mknl at 2,500 U/m2 every 3 weeks.
Adverse events during the trial included elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting. All adverse events were grade 3 or lower.The most common (incidence ≥ 10%) grade ≥ 3 adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. In a randomized trial, the safety profile of calaspargase pegol-mknl administered every 3 weeks was similar to that of pegaspargase administered every 2 weeks.
The recommended dose is 2,500 units/m2 administered intravenously every 3 weeks.