FDA Grants Breakthrough Therapy Designation for Acalabrutinib

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

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