August 1, 2017 – Today the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for acalabrutinib for the treatment of people with mantle cell lymphoma (MCL) who have received at least one prior therapy
While this news is for folks with mantle cell lymphoma, a cousin cancer to CLL, this is not an usual path to broader ultimate approval of a new medication.
Also, once a medication is approved, it can be used for any indication. though such “off label” insurance coverage can be a challenge
Overall, very good news
Read more: https://www.astrazeneca-us.com/media/press-releases/2017/acalabrutinib-granted-breakthrough-therapy-designation-by-us-fda-for-the-treatment-of-patients-with-mantle-cell-lymphoma-08012017.html