The U.S. FDA just granted breakthrough therapy designation to a new mantle cell lymphoma treatment called acalabrutinib!
This drug is specifically for people who have already gone through at least one previous therapy, i.e. for refractory or relapsed mantle cell lymphoma. It is urgent that new treatments are developed for patients with this type of rare cancer, especially for those that have not responded well to current treatment measures, such as chemotherapy and/or radiation.
Mantle cell lymphoma is a type of non-Hodgkin’s lymphomas that develop from cancerous white blood cells in the mantle zone.
These cells can multiply uncontrollably, spreading to various other parts of the body and creating a whirlwind of additional complications in the people it affects. Current treatment for mantle cell lymphoma are not nearly as effective and tolerable as they should be, especially for patients with highly resistant strains of the cancer. To learn more about mantle cell lymphoma, click here.
The FDA formed this breakthrough therapy designation decision on clinical trial findings from the development program for acalabrutinib, including using this drug both as a monotherapy and as a combination therapy (specifically in the Phase 2 ACE-LY-004 trial). Overall, this breakthrough therapy designation will help AstraZeneca, the developers of acalabrutinib, bring this possible treatment to patients as soon as possible.
So how is acalabrutinib different from current treatments for mantle cell lymphoma?
Acalabrutinib is a highly-selective and potent Bruton tyrosine kinase inhibitor, which works to treat the underlying biological cause of mantle cell lymphoma. In fact, after a 3-year follow-up with participants of the trial, the drug was shown to be effective and well-tolerated, without toxicity.
These encouraging results helped warrant the FDA’s ruling on acalabrutinib, and hopefully, the process for bringing this drug to market will be expedited in the coming months!
In the meantime, to learn more about the FDA’s decision from Healio, click here!
To learn more about Bruton tyrosine kinase inhibitors, click here!