All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

  TRANSLATE

The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

The Lymphoma & CLL Hub is an independent medical education platform, sponsored by AbbVie, BeOne Medicines, Johnson & Johnson, Roche, and Sobi, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer.   View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

FDA grants Breakthrough Therapy Designation to acalabrutinib for adult patients with CLL

Featured:

Paolo GhiaPaolo Ghia

Aug 15, 2019


On the 14th of August 2019 the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for acalabrutinib as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL).

Acalabrutinib, is an inhibitor of Bruton tyrosine kinase (BTK) involved in pathways regulating B-cell proliferation, chemotaxis, and adhesion. The decision was based on positive results from the interim analyses of two phase III clinical trials, ELEVATE-TN and ASCEND.

The drug was previously granted accelerated approval for the treatment of adult patients with R/R mantle cell lymphoma (MCL). Acalabrutinib is also currently being evaluated, as a monotherapy and in combination, in 26 clinical trials in indications including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, follicular lymphoma, and multiple myeloma.

Expert Opinion

Paolo GhiaPaolo Ghia

References

Your opinion matters

Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?