Treats previously untreated mantle cell lymphoma (MCL). NDA 210259, held by Astrazeneca. Acalabrutinib.
As of Nov 13, 2026, NDA 210259 (Calquence), held by Astrazeneca, was first approved by FDA on Oct 31, 2017, with 6 approved supplements and 0 published complete response letters.
CALQUENCE is a kinase inhibitor indicated:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2026 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jan 16, 2025 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2019 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2019 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Oct 31, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calquence100MG · capsule;oral | Acalabrutinib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2026 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jan 16, 2025 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Jun 5, 2024 | Supplement 10Labeling | Approved | |
| Mar 24, 2022 | Supplement 9Labeling · Standard review | Approved | |
| Nov 21, 2019 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2019 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Oct 31, 2017 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
