FDA approves expanded Imbruvica indication

SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Janssen Biotech’s and Pharmacyclics’ Imbruvica (ibrutinib) capsules, the companies announced Friday.

 

The drug can now be used by patients with chronic lymphocytic leukemia that hasn’t been treated yet. The new indication expands the drug’s use beyond CLL patients with a certain genetic mutation. The approval coincides with a recent update to the National Comprehensive Cancer Network’s Clinical Practice Guidelines, which recommended Imbruvica for some first-line CLL patients.