Jazz Pharmaceuticals Announces U.S. FDA Approval of Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma
Rylaze was first approved in the
"With the addition of a Monday/Wednesday/Friday dosing schedule for Rylaze, patients will have another dosing option, which provides sustained asparaginase activity throughout the entire course of Rylaze treatment," said
"The expansion of the Rylaze label to include a Monday/Wednesday/Friday dosing schedule provides another option to support patients in completing their planned asparaginase treatment regimen. The benefit of completing the full course of asparaginase has been shown in various publications, and discontinuation of asparaginase has been associated with inferior disease-free survival," said Dr.
The MWF dosing option was approved by the FDA under the RTOR program based on data from the intramuscular administration part of the Phase 2/3 trial (JZP458-201 or AALL1931), which was developed and conducted in close collaboration with the
Results show that a dosing regimen of 25 mg/m2 administered intramuscularly on Monday morning and Wednesday morning, and 50 mg/m2 administered on Friday afternoon demonstrated a positive benefit-to-risk profile, with ≥90% of the patients achieving nadir serum asparaginase activity (NSAA) ≥0.1 U/mL by simulation.1
Overall, the safety profile of Rylaze was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy. There were no new safety signals observed in the trial.1
Rylaze was granted orphan drug designation for the treatment of ALL/LBL in
About Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the
Important Safety Information
Rylaze should not be given to people who have had:
- Serious allergic reactions to Rylaze
- Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
Rylaze may cause serious side effects, including:
- Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
- Swelling of the pancreas (stomach pain)
- Blood clots (may have a headache or pain in leg, arm, or chest)
- Liver problems
Contact your doctor immediately if any of these side effects occur.
Some of the most common side effects with Rylaze include: liver problems, nausea, bone and muscle pain, infection, tiredness, headache, fever with low white blood cell count, fever, bleeding, mouth swelling (sometimes with sores), pain in the abdomen, decreased appetite, serious allergic reactions, a high blood sugar level, diarrhea, swelling of the pancreas and low levels of potassium in your blood.
Rylaze can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving Rylaze and for 1 week after the final dose.
Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.
These are not all the possible side effects of Rylaze. For more information, ask your healthcare provider.
Call your doctor for medical advice about any side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can be fast growing.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.5 The American Cancer Society estimates that about 6,600 new cases of ALL will be diagnosed in the United States in 2022.5
About Lymphoblastic Lymphoma
Lymphoblastic lymphoma (LBL) is a rare, fast-growing, aggressive subtype of non-Hodgkin's lymphoma (NHL), most often seen in children and teenagers.6 In LBL, the abnormal lymphocytes are present in the lymph nodes or thymus gland, whereas in ALL, the abnormal lymphocytes are mainly in the blood and bone marrow.6
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1 Maese L, Loh M.L.,
2 National Cancer Institute. Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/acute-lymphoblastic-leukemia. Accessed Nov. 17, 2022.
3 American Cancer Society. Key Statistics for Childhood Leukemia. https://www.cancer.org/cancer/leukemia-in-children/about/key-statistics.html. Accessed Nov. 17, 2022.
4 Pui C, Evans W. A 50-Year Journey to Cure Childhood Acute Lymphoblastic Leukemia. Seminars in Hematology. 2013;50(3), 185-196.
5 American Cancer Society. Key Statistics for Acute Lymphocytic Leukemia. Available at: https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html. Accessed Nov. 17, 2022.
6 Leukaemia Foundation. Lymphoblastic Lymphoma. Available at https://www.leukaemia.org.au/disease-information/lymphomas/non-hodgkin-lymphoma/other-non-hodgkin-lymphomas/lymphoblastic-lymphoma/. Accessed
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