Earlier this month, Janssen/Pharmacyclics announced they had submitted a New Drug Application (NDA) for Food & Drug Administration (FDA) approval of ibrutinib, an oral Bruton’s tyrosine kinase inhibitor (BTK) in chronic lymphocytic leukemia (CLL) for the treatment of patients with a deletion of the short arm of chromosome 17 (del17p). Here’s a link to July 10 press release.

The company have requested Priority review; approval later this year or in early 2014 is highly likely given that the agent has also been designated a Breakthrough Therapy by the FDA.

This is great news for CLL patients!

CLL is an incurable disease. It is the most common leukemia in the United States with 15,500 new diagnoses a year.

Chromosomal abnormalities are fairly common in CLL and predict both time to first treatment and overall survival i.e. how long someone will live. Sadly, those with a 17p deletion have the worst outcome and a poor prognosis.

Subscribers can login to read more or you can purchase access by clicking on the blue icon at the end of the post.

Posted by 

Purchase Access to Premium Content

Click on blue icon to purchase personal access to all Premium Content. Current subscription rate is $399 for 3 months access and $1200 for 12 months access. Please contact us if you would like to purchase annual access. Subscriptions do not auto renew. Rates may change without notice and are non-refundable. Please read the Terms of Use before purchasing and if in communications our Guidance to PR Professionals.