FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.

FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.
Clin Cancer Res. 2019 Aug 23;:
Authors: Li RJ, Jin R, Liu C, Cao X, Manning ML, Di XM, Przepiorka D, Namuswe F, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R
Abstract
On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (CALASP), 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. Efficacy was determined based on achievement and maintenance of steady-state nadir serum asparaginase activity (NSAA) above 0.1 U/mL when using CALASP, 2500 U/m2 intravenously, every 3 weeks. In a randomized comparison to pegaspargase (PEGASP) every 2 weeks, treatment with CALASP every 3 weeks had a similar safety profile and no substantial impairment in event-free survival. The pharmacokinetics of CALASP were studied when administered in combination with multiagent chemotherapy in 124 patients with B-cell ALL in Study AALL07P4 and Study DFCI 11-001. The results showed that 123 (99%, 95% confidence interval (CI): 96%-100%) of the 124 patients maintained NSAA > 0.1 U/mL at weeks 6, 12, 18, 24 and 30 of post-induction phase. Maintaining adequate NSAA levels is critical to successful treatment of ALL. Herein we describe the FDA review and approval of CALASP.
...

Source: Clinical Cancer Research - August 22, 2019 Category: Cancer & Oncology Authors: Li RJ, Jin R, Liu C, Cao X, Manning ML, Di XM, Przepiorka D, Namuswe F, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R Tags: Clin Cancer Res Source Type: research