Treats acute lymphoblastic leukemia. BLA 761102, held by Servier Pharma LLC. Calaspargase Pegol-Mknl.
As of Nov 13, 2026, BLA 761102 (Asparlas), held by Servier Pharma LLC, was first approved by FDA on Dec 20, 2018, with 4 approved supplements and 0 published complete response letters.
ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. 1.1 Acute Lymphoblastic Leukemia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Asparlas3750UNITS/5ML · injectable;intravenous | Calaspargase Pegol-Mknl | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Dec 21, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jun 24, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Sep 5, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Dec 20, 2018 | 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
