Jazz Pharmaceuticals Receives CHMP Positive Opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
"Today's positive CHMP opinion is welcome news for those in the ALL and LBL community who are unable to be treated with E. coli-derived asparaginase due to hypersensitivity reactions," says
The CHMP's recommendation will now be reviewed by the
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.1,2 ALL is the most common childhood malignancy, accounting for 80% of leukemia diagnoses in children, compared to 20% of adults.3 Long-term survival rates for pediatric patients have improved significantly over the last few decades.4 The estimated overall incidence of ALL and lymphoblastic lymphoma (LBL) in
Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL,6 however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase,7 necessitating treatment discontinuation or a switch to a non-E. coli-derived asparaginase preparation.8 Patients not receiving asparaginase due to hypersensitivities and those not receiving all prescribed doses have been shown to have poor outcomes.9,10
About Lymphoblastic Lymphoma (LBL)
Lymphoblastic Lymphoma (LBL) is a rare, fast-growing, aggressive subtype of non-Hodgkin's lymphoma (NHL), which is very rare in adults and is most often seen in teenagers and young adults under the age of 35.11,12 LBL is a type of high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.12 LBL is the second most common type of NHL in childhood and adolescence, accounting for 25-35% of cases.13
JZP458 is a recombinant Erwinia asparaginase or crisantaspase that uses a Pseudomonas fluorescens expression platform.9 It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who developed hypersensitivity to E. coli-derived asparaginase products. JZP458 was approved by the
About Jazz Pharmaceuticals plc
Head of Strategic Brand Engagement
Vice President, Head, Investor Relations
3 Chennamadhavuni A, et al. Leukemia. In: StatPearls [Online].
4 Neaga A, et al. Why do children with acute lymphoblastic leukemia fare better than adults? Cancers (
5 Hoelzer D, et al. Acute lymphoblastic leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v69–v82.
6 Salzer W, Bostrom B, Messinger Y, et al. Asparaginase activity levels and monitoring in patients with acute lymphoblastic leukemia. Leuk Lymphoma. 2018;59(8):1797-1806. DOI 10.1080/10428194.2017.1386305.
7 van der Sluis IM, et al. Consensus expert recommendations for identification and management of asparaginase hypersensitivity and silent inactivation. Haematologica. 2016;101(3):279–285.
8 Hijiya N, van der Sluis IM. Asparaginase-associated toxicity in children with acute lymphoblastic leukemia. Leuk Lymphoma. 2016;57(4):748-757. DOI 10.3109/10428194.2015.1101098.
9 Maese L, Rizzari C, Coleman R, et al. Can recombinant technology address asparaginase Erwinia chrysanthemi shortages? Pediatr Blood Cancer. 2021;68(10):e29169. DOI 10.1002/pbc.29169.
10 Gupta S, Wang C, Raetz EA, et al. Impact of asparaginase discontinuation on outcome in childhood acute lymphoblastic leukemia: a report from the children's oncology group. J Clin Oncol. 2020;38(17):1897-1905. DOI 10.1200/JCO.19.03024.
13 Burkhardt B, et al. Lymphoblastic lymphoma in children and adolescents: review of current challenges and future opportunities. Br
Updated 2021. Accessed
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