Treats acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). BLA 761179, held by Jazz Pharms. Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn.
As of Nov 13, 2026, BLA 761179 (Rylaze), held by Jazz Pharms, was first approved by FDA on Jun 30, 2021, with 3 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 30, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rylaze10MG/0.5ML · injectable;intramuscular | Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Nov 18, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jul 15, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 30, 2021 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
