Imbruvica Approved for Expanded Use and New Labeling

On July 28, 2014, the FDA announced approval of the expanded use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion). Imbruvica was granted Breakthrough Therapy designation for this use. In addition, the FDA approved new labeling to reflect that the clinical benefit in treating CLL with Imbruvica has been verified.

Imbruvica is approved for the treatment of CLL in patients who have received at least 1 prior therapy. The recommended dosage in patients with CLL is 420 mg orally once daily (three 140-mg capsules once daily).

Imbruvica is also approved for the treatment of mantle cell lymphoma in patients who have received at least 1 prior therapy. The recommended dosage is 560 mg taken orally once daily (four 140-mg capsules once daily). Continued approval for this indication may be contingent on verification of clinical benefit in confirmatory trials.

Imbruvica capsules should be taken orally with a glass of water and should not be opened, broken, or chewed. There are no contraindications for use.

Imbruvica is a product of Pharmacyclics and Janssen Biotech. For more information, visit www.imbruvica.com.