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Release date: 2026-03-25 13:54:05 Recommended: 7
Pirtobrutinib is a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor developed by Eli Lilly in the United States. It was first approved by the U.S. FDA on January 27, 2023, for the treatment of relapsed or refractory mantle cell lymphoma in adults. Subsequently, on December 1, 2023, it was approved for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
Pirtobrutinib is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma who have previously received treatment with a covalent BTK inhibitor.
Indicated for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a BTK inhibitor.
Pirtobrutinib is the first non-covalent (reversible) BTK inhibitor approved by the FDA. It can re-establish BTK inhibition in patients previously treated with covalent BTK inhibitors (ibrutinib, acalabrutinib, or zanubrutinib) and expand the benefits of targeted BTK pathway therapy.
Mantle cell lymphoma is a rare blood cancer and a form of non-Hodgkin lymphoma. It arises in B lymphocytes, a type of white blood cell that is part of the immune system. Mantle cell lymphoma typically originates in B cells located in the outer mantle zone of lymph nodes. As the cancer progresses, it can spread to the bone marrow, spleen, liver, or digestive tract.
Chronic lymphocytic leukemia and small lymphocytic lymphoma are slow-growing non-Hodgkin lymphomas that develop from white blood cells called lymphocytes. Chronic lymphocytic leukemia is one of the most common types of leukemia in adults. From a pathological and immunophenotypic perspective, small lymphocytic lymphoma is identical to chronic lymphocytic leukemia, with the main difference being the location of the cancer cells. In chronic lymphocytic leukemia, cancer cells are present in the blood, whereas in small lymphocytic lymphoma, they are found in the lymph nodes.
