Drugs / Asparaginase Erwinia chrysanthemi
Asparaginase Erwinia chrysanthemi
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed lymphoblastic leukemia, acute, with lymphomatous features 1 milestone | |||||
| Filed | EU (EMA) | Rylaze | lymphoblastic leukemia, acute, with lymphomatous features | — | “Completed Marketing Authorization Application (MAA) submission for JZP458 (approved as Rylaze in the U.S. ) to European Medicines Agency (EMA) in May 2022.” jazzpharma.com ↗ “submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency for JZP458” jazzpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | RYLAZE | — | 2022-11-18 | fda.gov ↗ |
| Approved | US (FDA) | RYLAZE | — | 2021-06-30 | fda.gov ↗ |
Trials 22
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-11-30 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present New Data Highlighting Advancements in Solid Tumors and Rare Blood Cancers at Upcoming Oncology Meetings jazzpharma.com ↗
The combination of observed and modeled results demonstrates Rylaze achieved therapeutic nadir serum asparaginase activity (NSAA) levels in the vast majority of patients via multiple dosing schedules with a safety profile consistent with prior studies and no new safety signals identified. |
| 2023-09-22 | Ligand Pharmaceuticals | Regulatory Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma ligand.com ↗
We congratulate our partner Jazz on its receipt of approval for Enrylaze® from the European Commission, expanding the market opportunity for one of our key commercial-stage products,” said Todd Davis, CEO of Ligand Pharmaceuticals. |
| 2023-09-21 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma jazzpharma.com ↗
The approval of Enrylaze now provides an important option to support patients in completing their planned asparaginase treatment regimen. |
| 2023-07-21 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Receives CHMP Positive Opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma jazzpharma.com ↗ |
| 2022-11-18 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces U.S. FDA Approval of Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze ® (asparaginase erwinia chrysanthemi (recombinant)-rywn). |
| 2022-11-03 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Data at 2022 ASH Meeting Showcasing Commitment to Advancing Oncology Research jazzpharma.com ↗
Results demonstrate that IV administration of Rylaze at 25 mg/m 2 every 48 hours is feasible and efficacious with a safety profile consistent with other asparaginases. |
| 2022-06-07 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Positive Data from Phase 2/3 Trial of Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) in Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma at the ASCO 2022 Annual Meeting jazzpharma.com ↗ |
| 2022-02-02 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Completes U.S. FDA Supplemental Biologics License Application for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) Monday/Wednesday/Friday Dosing Schedule jazzpharma.com ↗ |
| 2021-12-12 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Positive Interim Phase 2/3 Results of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) in Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma at ASH 2021 Annual Meeting jazzpharma.com ↗
Three cohorts with unique, IM administration dosing schedules were evaluated in the trial, demonstrating a safety profile consistent with other asparaginases. |
| 2021-06-30 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma jazzpharma.com ↗ |
| 2020-12-21 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces Initiation of Biologics License Application Submission for JZP-458 for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma jazzpharma.com ↗
The BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. |
| 2019-08-06 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Advances Recombinant Crisantaspase Development Program jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Phase 1 study of its recombinant crisantaspase molecule, JZP-458, met its efficacy and safety objectives. |
| 2014-12-19 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze® (asparaginase Erwinia chrysanthemi) jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration ( FDA ) approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi ). |
| 2012-12-10 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Announces Presentation Of Largest Safety Trial To Date Of Patients Treated With Erwinaze® jazzpharma.com ↗
The trial includes additional follow up data that further describe the incidence of adverse events associated with Erwinaze treatment, which are consistent with the known safety profile of Erwinaze. |
All press releases naming this drug 19 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asparaginase Erwinia chrysanthemi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02981628 ↗ |
| Known as | Asparaginase Erwinia Chrysanthemi (recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07059975 ↗ |
| Known as | asparaginase erwinia chrysanthemi [recombinant]-rywn | “AALL1931, a phase 2/3 study conducted in collaboration with the Children's Oncology Group, investigated the efficacy and safety of JZP458 (asparaginase erwinia chrysanthemi...” PMID 36108304 ↗ Feb 2023 |
| Known as | Cirsantaspase | “switch to Erwinia asparaginase/Cirsantaspase 25 000 U/m² with the same drug regimen” NCT03599960 ↗ |
| Known as | Crisantaspase | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗1“Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)” NCT02150928 ↗ |
| Known as | Erwinase? | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗12“Patient with allergic reaction to Pegaspargase can be given Erwinase IM/IV on Mon/Wed/Fri (or every other day per institutional standard) x 6 doses for each dose of Pegaspargase” NCT03817320 ↗ “Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)” NCT02150928 ↗ “Drug: Erwinase®” NCT03117751 ↗ “Drug: Erwinase” NCT06336395 ↗ |
| Known as | Erwinaze | “Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)” NCT02150928 ↗ |
| Known as | Erwinia asparaginase | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗13“Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available),...” NCT04501614 ↗ “BACKGROUND: Erwinia asparaginase is antigenically distinct from E.coli-derived asparaginase and may be used after E.coli-derived asparaginase hypersensitivity.” PMID 26376459 ↗ Sep 2015 “each dose of PEG-asparaginase will be replaced by Erwinia-asparaginase at a dose of 20,000 units/m² IV or IM every other day for a total of 6 doses” NCT05748171 ↗ “switch to Erwinia asparaginase/Cirsantaspase 25 000 U/m² with the same drug regimen” NCT03599960 ↗ |
| Known as | Erwinia L-asparaginase | “Erwinia L-asparaginase may be substituted for pegaspargase” NCT01186328 ↗ |
| Known as | IND 290 | “Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic...” NCT00537030 ↗ |
| Known as | JZP458 | “AALL1931, a phase 2/3 study conducted in collaboration with the Children's Oncology Group, investigated the efficacy and safety of JZP458 (asparaginase erwinia chrysanthemi...” PMID 36108304 ↗ Feb 2023 |
| Known as | recombinant Erwinia asparaginase | “This phase I/Ib trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination...” NCT07133997 ↗ |
| Action | Inhibit | “JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.” NCT06738368 ↗ |
| Modality | Protein / enzyme biologic | “Asparaginase is a therapeutic enzyme used to treat leukemia and lymphoma” PMID 24970932 ↗ Jun 2014 |
| Route | Intramuscular | “E. coli asparaginase 10,000 U/m2/day IM (or Erwinia if previous allergy to E. coli)” NCT00187083 ↗ |