RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn)
RYLAZE is an asparagine-specific enzyme indicated for use as a component of a multi-agent chemotherapeutic regimen. It is approved for the treatment of adult and pediatric patients aged one month and older with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). This therapy is specifically used in patients who have developed hypersensitivity to E. coli-derived asparaginase.
How RYLAZE Works
This drug is a recombinant enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The therapeutic effect is achieved through the depletion of plasma asparagine, which leukemic cells require for survival. Because these leukemic cells have low expression of asparagine synthetase, they possess a reduced ability to synthesize their own asparagine and must rely on exogenous sources. Depleting the available supply of this amino acid leads to the death of the leukemic cells.
Details
- Status
- Prescription
- First Approved
- 2021-06-30
- Revenue
- $108M (Q4-2025)
- Routes
- INTRAMUSCULAR
- Dosage Forms
- INJECTABLE
RYLAZE Approval History
What RYLAZE Treats
3 indicationsRYLAZE is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Lymphoblastic Lymphoma
- Hypersensitivity
RYLAZE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in RYLAZE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RYLAZE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to RYLAZE
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03117751 | TOT17 NCI-2017-00582 | Ph 2, Ph 3 | active not recruiting | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RYLAZE FDA Label Details
Indications & Usage
FDA Label (PDF)RYLAZE is indicated for the treatment of Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Hypersensitivity.
Pro Intelligence Preview
Deep insights for RYLAZE
Revenue Insights
- • Q4-2025: $108M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 19 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.