FDA approves Asparlas as a component of a multi-agent chemotherapeutic regimen to treat acute lymphoblastic leukemia.- Servier

The FDA has approved Asparlas (calaspargase pegol-mknl) from Servier Pharmaceuticals LLC, an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products.

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.

Comment: In April 2018 Shire entered into a definitive agreement with Servierto sell its Oncology business for $2.4 billion. Shire�s Oncology business includes in-market products Oncaspar (pegaspargase), a component of multi-agent treatment for acute lymphoblastic leukemia (ALL) and ex-U.S. rights to Onivyde (irinotecan pegylated liposomal formulation), a component of multi-agent treatment for metastatic pancreatic cancer post gemcitabine-based therapy. The portfolio also included Calaspargase Pegol (Cal-PEG) ( formerly SHP 663).