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  • Acalabrutinib has received the ‘Breakthrough Therapy Designation’ from the US FDA for the treatment of mantle cell lymphoma
  • It is a Bruton tyrosine kinase (BTK) inhibitor that prevents the proliferation of the cancer cells
  • It provides an option for patients who have not responded or those who relapsed following initial treatment

The U.S. Food and Drug Administration (FDA) has approved the use of and granted the 'Breakthrough Therapy Designation' to the drug acalabrutinib for the treatment of adults with mantle cell lymphoma who have received at least one prior treatment. The oral drug will be useful for patients who did not respond to an earlier treatment or the cancer has relapsed following treatment, often leaving them with no other treatment option.

The approval comes following the initial successful results of a clinical trial that evaluated the use of acalabrutinib in patients with mantle cell lymphoma. The study was conducted on 124 patients who had received at least one prior treatment. In the study, 41 percent patients showed a complete shrinkage of the cancer while 40 percent patients showed a partial shrinkage of the cancer.
Acalabrutinib Receives ‘Breakthrough Therapy Designation’ in Mantle Cell Lymphoma

Acalabrutinib was earlier granted Orphan Drug Status by the US FDA for the treatment of mantle cell lymphoma, and by the European Commission for the treatment of patients with chronic lymphocytic leukemia and Waldenström macroglobulinemia along with mantle cell lymphoma.

Since the drug has been given accelerated approval, the studies to establish its efficacy and safety in mantle cell lymphoma will continue, and its approval could be revised in the future depending on the results.

Mantle Cell Lymphoma

Mantle cell lymphoma is a type of non-Hodgkin lymphoma cancer affecting the B cells of the immune system. It spreads very fast to the lymph nodes, bone marrow and other organs. In fact, it is often diagnosed in the late stages, when it has already spread, resulting in poor outcomes to treatment. It is usually treated using chemotherapy.

About Acalabrutinib

  Acalabrutinib is a drug that is classified as a Bruton tyrosine kinase (BTK) inhibitor. By blocking the kinase enzyme, it prevents the proliferation of the cancer cells.

Acalabrutinib is available as a 100 mg capsule that should be taken twice a day. The most common side effects include headache, diarrhea, tiredness, muscle aches, bruising and reduced blood counts. Other possible side effects include bleeding, increased risk of infections, the appearance of new cancers like skin cancer and heart rhythm problems. Currently, the safety of acalabrutinib in children has not been established and should not be used in them. It should also not be used by women breastfeeding their babies.

Acalabrutinib is also being evaluated for the treatment of other cancers like chronic lymphocytic leukemia, Waldenström macroglobulinemia, follicular lymphoma diffuse large B-cell lymphoma, and multiple myeloma.


  1. FDA approves new treatment for adults with mantle cell lymphoma - (

Source: Medindia

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