Calquence

Treats previously untreated mantle cell lymphoma (MCL). NDA 216387, held by Astrazeneca. Acalabrutinib Maleate.

As of Nov 13, 2026, NDA 216387 (Calquence), held by Astrazeneca, was first approved by FDA on Aug 3, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CALQUENCE is a kinase inhibitor indicated:

In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
For the treatment of adult patients with MCL who have received at least one prior therapy.
For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Feb 19, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 16, 2025	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 3, 2022	Original applicationNew dosage form · Standard review	Approved	Review Label
Aug 3, 2022	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
CalquenceEQ 100MG BASE · tablet;oral	Acalabrutinib Maleate	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Feb 19, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 16, 2025	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 5, 2024	Supplement 4Labeling	Approved	Letter Label
Aug 3, 2022	Original applicationNew dosage form · Standard review	Approved	Review Label
Aug 3, 2022	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: CALQUENCESep 9, 2025

Identifiers

Application: NDA 216387
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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