Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication RYLAZE is indicated 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 or older who have developed hypersensitivity to E. coli -derived asparaginase. FDA label
Also known as IM JZP-458, JZP-458, Asparaginase Erwinia chrysanthemi, Asparaginase Erwinia chrysanthemi (Recombinant)-rywn, Asparaginase Erwinia chrysanthemi-rywn, Crisantaspase, Crisantaspase Biobetter JZP-458, Crisantaspasum
Rylaze · 3 trials · 5 indications
The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination.
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Will be measured by multi-parameter flow cytometry (MFC). Will be assessed according to the National Comprehensive Cancer Network response criteria.
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
| Arm | Type | Description |
|---|---|---|
| JZP-458 | EXPERIMENTAL | Part A (IM JZP-458) of the study will have 2 IM cohorts: * Cohort 1: a JZP-458 repeat dose/confirmatory cohort; a final IM JZP-458 dose level will be selected, and * Cohort 2: an expansion cohort to confirm the efficacy and safety of the final IM JZP-458 dose level and schedule Part B (IV JZP-458 Dose Confirmation) will be conducted to define the optimal dose of the IV administration of JZP-458 for further study in ALL/LBL patients as a repeated dose. Additional courses of JZP-458 (IM or IV depending on patient's allocation at study enrollment) will be administered based on each patient's original treatment plan for as long as the patient derives clinical benefit. |
| Treatment (DA-EPOCH, rituximab, JZP458) | EXPERIMENTAL | Patients receive etoposide IV, doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone PO BID on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 IM every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim SC once or filgrastim SC QD until ANC \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo CT or PET/CT throughout the study. |
| Open-Label Erwinaze | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IM JZP-458 | DRUG | IM JZP-458 will be administered in Part A, Cohorts 1 \& 2 |
| IV JZP-458 | DRUG | IV JZP-458 will be administered in Part B |
| Asparaginase Erwinia chrysanthemi | DRUG | Given IM |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Collection | PROCEDURE | Undergo bone marrow sample collection |
| Computed Tomography | PROCEDURE | Undergo CT or PET/CT |
| Cyclophosphamide | DRUG | Given IV |
| Doxorubicin | DRUG | Given CIV |
| Etoposide | DRUG | Given CIV |
| Filgrastim | BIOLOGICAL | Given SC |
| Pegfilgrastim | BIOLOGICAL | Given SC |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
| Vincristine | DRUG | Given CIV |
Inclusion Criteria: 1. Pediatric and adult patients with a diagnosis of ALL or LBL. 2. Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation. 3. Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan. 4. Patients ...
Rylaze is used for acute lymphoblastic leukemia, a cancer of the blood and bone marrow. It is also studied in lymphoblastic lymphoma. Jazz Pharmaceuticals plc develops Rylaze, which has been evaluated in a Phase 2 clinical trial in patients with these conditions.
Rylaze is made by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. Jazz Pharmaceuticals is responsible for the development and manufacturing of Rylaze for acute lymphoblastic leukemia and related conditions.
Rylaze is in Phase 2 clinical development. A completed Phase 2 trial, NCT04145531, evaluated Rylaze in patients with acute lymphoblastic leukemia and lymphoblastic lymphoma. The trial enrolled 229 patients across the United States and Canada.
Rylaze has been studied in one clinical trial, NCT04145531, titled an open-label study of JZP-458 (RC-P) in patients with acute lymphoblastic leukemia and lymphoblastic lymphoma. This Phase 2 trial is completed and enrolled 229 patients in the United States and Canada.
Yes, Rylaze is also known as JZP-458 and IM JZP-458. These are alternative names for the same investigational drug developed by Jazz Pharmaceuticals plc for acute lymphoblastic leukemia and lymphoblastic lymphoma.