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.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your Lymphoma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The Lymphoma 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 Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub 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.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2017-11-01T10:07:13.000Z

The FDA grants Calquence® (acalabrutinib) accelerated approval for the treatment of R/R MCL

Nov 1, 2017
Share:

Bookmark this article

On 31st October 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Calquence® (acalabrutinib) for the treatment of adult mantle cell lymphoma (MCL) patients who have previously received at least one therapy. The accelerated approval for AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor follows prior granting of Breakthrough Therapy Designation, and Priority Review in August 2017.

This approval was based on data from the ACE-LY-004 trial (NCT02213926). This is a phase II, open-label study aiming to determine the safety and efficacy of Calquence® (acalabrutinib) in patients with relapsed/refractory (R/R) MCL. Reported key investigator assessed efficacy results from 124 patients recruited to the ACE-LY-004 trial included an overall response rate of 81% (95% CI: 73–87), and a complete response rate of 40% (95% CI: 31–49), with a median follow-up of 15.2 months.

The full indication and usage from the prescribing information is as follows:

CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

These results from the ACE-LY-004 trial are the first MCL data announced from AstraZeneca’s Calquence® (acalabrutinib) development program investigating monotherapy and combination regimens in a wide range of solid and hematological tumors. One such ongoing phase III trial (ACE-LY-308) is evaluating the potential of front-line Calquence® (acalabrutinib) in combination with rituximab and bendamustine in the treatment of MCL (NCT02972840). Additional studies are also ongoing including a phase II study of acalabrutinib in R/R Chronic Lymphocytic Leukemia (CLL) and newly diagnosed del(17p) CLL (NCT02337829), and a broader phase I/II trial of acalabrutinib combined with the PI3K inhibitor ACP-319 in B-cell malignancies (NCT02328014).

Understanding your specialty helps us to deliver the most relevant and engaging content.

Please spare a moment to share yours.

Please select or type your specialty

  Thank you

Newsletter

Subscribe to get the best content related to lymphoma & CLL delivered to your inbox