DUBLIN, July 21,
2023 /PRNewswire/ -- Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) today announced that the European Medicines Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP) adopted
a positive opinion recommending the marketing authorization of
JZP458 (a recombinant Erwinia asparaginase or
crisantaspase) for use as a component of a multi-agent
chemotherapeutic regimen for the treatment of acute lymphoblastic
leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and
pediatric patients (1 month and older) who developed
hypersensitivity or silent inactivation to E. coli-derived
asparaginase.
"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 Robert Iannone, MD., M.S.C.E.,
executive vice president, global head of research and development
of Jazz Pharmaceuticals. "We look forward to receiving the final
decision that will help bring us one step closer to delivering a
reliable supply of recombinant Erwinia asparaginase to
patients in the European Union."
The CHMP's recommendation will now be reviewed by the European
Commission (EC), which has the authority to approve medicines in
all European Union Member States, Iceland, Norway, and Liechtenstein, and is expected to make a final
decision soon.
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 Europe is 1.28
per 100,000.5
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
About JZP458
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 U.S. Food and
Drug Administration (FDA) in June
2021 for the treatment of this patient population and became
commercially available in July of the same year in the
U.S.14
About Jazz Pharmaceuticals plc
Jazz
Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical
company whose purpose is to innovate to transform the lives of
patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases—often with
limited or no therapeutic options. We have a diverse portfolio of
marketed medicines and novel product candidates, from early- to
late-stage development, in neuroscience and oncology. We are a
leader in sleep disorders and epilepsy; further developing in
movement disorders and PTSD; and focused on hematologic
malignancies and solid tumors. Within these therapeutic areas, we
are identifying new options for patients by actively exploring
small molecules and biologics, and through innovative delivery
technologies and cannabinoid science. Jazz is headquartered in
Dublin, Ireland, and has employees
around the globe, serving patients in nearly 75 countries. Please
visit www.jazzpharmaceuticals.com for more information.
Media Contact:
Kristin
Bhavnani
Head of Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Investors:
Andrea N.
Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
References
1 National Cancer Institute. Adult
acute lymphoblastic leukemia treatment
(PDQ®)–Patient Version. Cancer.gov. Updated November 19, 2021. Accessed July 02, 2023.
www.cancer.gov/types/leukemia/patient/adult-all-treatment-pdq.
2 National Cancer Institute. Childhood
acute lymphoblastic leukemia treatment (PDQ®)–Patient Version.
Cancer.gov. Updated September 02,
2022. Accessed July 02,
2023.
https://www.cancer.gov/types/leukemia/patient/child-all-treatment-pdq.
3 Chennamadhavuni A, et al. Leukemia. In:
StatPearls [Online]. Treasure
Island (FL). StatPearls Publishing. Updated January 17, 2023. Accessed July 02, 2023.
https://www.ncbi.nlm.nih.gov/books/NBK560490/.
4 Neaga A, et al. Why do children with acute
lymphoblastic leukemia fare better than adults? Cancers
(Basel). 2021;13(15):3886.
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.
11 Leukemia Foundation. Lymphoblastic lymphoma.
Leukaemia.org.au. Updated June 18,
2019. Accessed July 02, 2023.
https://www.leukaemia.org.au/blood-cancer/lymphoma/non-hodgkin-lymphoma/lymphoblastic-lymphoma/.
12 Macmillan Cancer Support. Cancer information and
support – lymphoblastic lymphoma. Macmillan.org.uk. Updated
January 31, 2021. Accessed
July 02, 2023.
https://www.macmillan.org.uk/cancer-information-and-support/lymphoma/non-hodgkin/types/lymphoblastic.
13 Burkhardt B, et al. Lymphoblastic lymphoma in
children and adolescents: review of current challenges and future
opportunities. Br J Haematol. 2019;185(6):1158–1170.
14 U.S. Food and Drug Administration. Rylaze
prescribing information. Accessdata.fda.gov.
Updated 2021. Accessed July 02, 2023.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761179s000lbl.pdf.
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