What are the names of the BTK inhibitors?

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Accepted Answer

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

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

Treatment for adult patients with:

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- with 17p deletion.
Waldenström’s Macroglobulinemia

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

Chronic Graft Versus Host Disease
- after failure of one or more lines of systemic therapy.

FDA Approved: October 31, 2017
Company: AstraZeneca

Treatment for adult patients with:

Mantle Cell Lymphoma
- 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.
• for the treatment of adult patients with MCL who have received at least one prior therapy.
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

FDA Approved: November 14, 2019
Company: BeOne Medicines USA, Inc.

Treatment for adult patients with:

Mantle Cell Lymphoma
- 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
Marginal Zone Lymphoma (relapsed or refractory)
- 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 or Small Lymphocytic Lymphoma
Follicular Lymphoma (relapsed or refractory)
- in combination with obinutuzumab, after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response
rate and durability of response. Continued approval for this indication may
be contingent upon verification and description of clinical benefit in a
confirmatory trial.

Jaypirca (pirtobrutinib) Tablets

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

Treatment for adult patients with:

Mantle Cell Lymphoma (relapsed or refractory)
- after at least two lines of systemic therapy, 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.
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 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.

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