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.
has received the 'Breakthrough Therapy Designation' from the US FDA for
the treatment of mantle cell lymphoma
is a Bruton tyrosine kinase
(BTK) inhibitor that prevents the proliferation of the cancer cells
provides an option for patients who have not responded or those who
relapsed following initial treatment
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, a Bruton tyrosine kinase (BTK) inhibitor, has received the ‘Breakthrough Therapy Designation’ from the US FDA for the treatment of relapsed or non-responding cases of 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
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
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
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.
- FDA approves new treatment for adults with mantle cell lymphoma - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm)