PharmaRadar360

PharmaRadar360

OncologyDrug intelligence

Calquence

Acalabrutinib

Covalent Bruton's tyrosine kinase (BTK) inhibitor. Developed by AstraZeneca. Clinical, regulatory, and source evidence are connected below.

Company
AstraZeneca
Target / MOA
BTK
Aliases
Calquence 路 ACP-196
Signals
22
Clinical trials
20
Approvals
1
Evidence sources
22

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

Phase 2 路 RECRUITING 路 National Cancer Institute (NCI)

clinical trialClinicalTrials.gov

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

Phase 3 路 ACTIVE_NOT_RECRUITING 路 Acerta Pharma BV

clinical trialClinicalTrials.gov

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Phase 3 路 ACTIVE_NOT_RECRUITING 路 Acerta Pharma BV

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Calquence capsules 路 NDA210259 路 label version 27, effective Feb 19, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 1.2 Previously Treated Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. 1.3 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Calquence tablets 路 NDA216387 路 label version 9, effective Feb 19, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 1.2 Previously Treated Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. 1.3 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

European Union (EMA)

Calquence 路 EMEA/H/C/005299 路 Authorised, authorised Nov 5, 2020 (Commission decision C(2020) 7760) 路 EPAR

Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

NDA210259 路 ASTRAZENECA 路 first approved Oct 31, 2017

4 efficacy supplements approved

NDA216387 路 ASTRAZENECA 路 first approved Aug 3, 2022

2 efficacy supplements approved

European Union

  • Calquence: Authorised since Nov 5, 2020

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

NDA210259 (Orange Book)

9 listed patents, latest expiry Jul 1, 2036
  • US 7459554 路 expires Nov 24, 2026 路 drug substance
  • US 10239883 路 expires Jul 11, 2032 路 U-2668, U-2666
  • US 9290504 路 expires Jul 11, 2032 路 drug substance, drug product
  • US 9758524 路 expires Jul 11, 2032 路 U-4108, U-2145
  • US 10272083 路 expires Jan 21, 2035 路 U-2519, U-2683, U-2686, U-2684, U-2687, U-2682, U-2685, U-4109
  • US 11771696 路 expires Jan 21, 2035 路 U-3710
  • US 11166951 路 expires Aug 11, 2035 路 U-4426, U-4431, U-4430, U-4429, U-4428, U-4427
  • US 10167291 路 expires Jul 1, 2036 路 drug product, U-2667, U-2670, U-2666, U-2668, U-2669, U-2671, U-4109, U-2519, U-2684, U-2685, U-2682, U-2683, U-2687, U-2686, U-2145
  • US 9796721 路 expires Jul 1, 2036 路 drug substance, drug product, U-2145, U-2669, U-2671, U-2670, U-2668, U-2666, U-2667, U-4108

Exclusivity: ODE-274 until Nov 21, 2026; I-960 until Jan 16, 2028; D-200 until Feb 19, 2029 路 Orange Book entry

NDA216387 (Orange Book)

8 listed patents, latest expiry Jul 1, 2036
  • US 7459554 路 expires Nov 24, 2026 路 drug substance
  • US 10239883 路 expires Jul 11, 2032 路 U-2666, U-2668
  • US 9290504 路 expires Jul 11, 2032 路 drug substance, drug product
  • US 9758524 路 expires Jul 11, 2032 路 U-4108, U-2145
  • US 10272083 路 expires Jan 21, 2035 路 U-4109, U-2519, U-2682, U-2683, U-2684, U-2685, U-2686, U-2687
  • US 11771696 路 expires Jan 21, 2035 路 U-3710
  • US 11166951 路 expires Aug 11, 2035 路 U-4426, U-4427, U-4428, U-4429, U-4430, U-4431
  • US 11059829 路 expires Jul 1, 2036 路 drug substance, drug product, U-4108, U-2145, U-2671, U-2670, U-2669, U-2668, U-2667, U-2666

Exclusivity: I-960 until Jan 16, 2028; D-200 until Feb 19, 2029 路 Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US labels have no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 20 linked records.

Phase 2RECRUITINGNCT04002947

Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

National Cancer Institute (NCI) 路 Updated Oct 16, 2026

Phase 3ACTIVE NOT RECRUITINGNCT04529772

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

Acerta Pharma BV 路 Updated Oct 13, 2026

Phase 3ACTIVE NOT RECRUITINGNCT02972840

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Acerta Pharma BV 路 Updated Oct 8, 2026

Phase 2ACTIVE NOT RECRUITINGNCT04783415

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

City of Hope Medical Center 路 Updated Oct 6, 2026

Phase 2RECRUITINGNCT04404088

Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma

M.D. Anderson Cancer Center 路 Updated Oct 6, 2026

Phase 2ACTIVE NOT RECRUITINGNCT04189757

Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma

M.D. Anderson Cancer Center 路 Updated Oct 6, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 16, 202620FDAofficial 路 Latest Feb 19, 20261EMA Human Medicinesofficial 路 Latest Oct 7, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.