New Guidance on Acceptable NDMA and NDEA Levels in ARBs
December 20, 2018Ultomiris Approved to Treat Rare Blood Disorder
December 21, 2018Asparlas Approved to Treat Acute Lymphoblastic Leukemia
December 20, 2018 – The U.S. FDA has approved AsparlasTM (calaspargase pegol-mknl), manufactured by Servier Pharmaceuticals, for use in combination with chemotherapy to treat patients who are between the ages of one month and 21 years, and have acute lymphoblastic leukemia (ALL).
Asparlas is an asparagine-specific enzyme, which combats ALL by helping to starve cancerous cells of asparagine, a key amino acid they need to survive. Although similar products are already available on the U.S. market, Asparlas allows a longer interval between doses.
The recommended dosing is 2,500 units/m 2 of body surface area administered intravenously, with at least 21 days between doses. Other available asparagine-specific enzyme products having dosing intervals as frequent as three times per week or once every 14 days.
Servier plans to launch the product during the first quarter of 2019. Pricing is not yet available.