The Bruton's tyrosine kinase (BTK) inhibitors include Imbruvica (ibrutinib), Calquence (acalabrutinib), Brukinsa (zanubrutinib), and Jaypirca (pirtobrutinib).

Imbruvica (ibrutinib) Capsules, Tablets, and Oral Suspension

FDA Approved: November 13, 2013
Company: Janssen Biotech, Inc.

Treatment for adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.
  Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
• Waldenström’s macroglobulinemia (WM).
• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
  Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Treatment of adult and pediatric patients age 1 year and older with:

• Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

Calquence (acalabrutinib) Capsules and Tablets

FDA Approved: October 31, 2017
Company: AstraZeneca

Treatment for adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.
  This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
• Chronic lymphocytic leukemia (CLL) or Small lymphocytic lymphoma (SLL).

Brukinsa (zanubrutinib) Capsules

FDA Approved: November 14, 2019
Company: BeiGene, Ltd.

Treatment for adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.
  This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Waldenström’s macroglobulinemia (WM).
• Marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
  This indication is approved under accelerated approval based on overall
  response rate. Continued approval for this indication may be contingent upon
  verification and description of clinical benefit in a confirmatory trial.
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Jaypirca (pirtobrutinib) Tablets

FDA Approved: January 27, 2023
Company: Eli Lilly and Company

Treatment for adult patients with:

• Mantle cell lymphoma (MCL) who have received at least two prior therapies, including a BTK inhibitor.
  This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.