FDA approves Biologics’ IMBRUVICA as oral agent for treatment of patients with CLL

Biologics, a limited distribution network partner for IMBRUVICA™ (ibrutinib), is pleased to announce the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules as a single, oral agent for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. The drug was originally approved on November 13, 2013 for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Both indications are based on overall response rate. An improvement in survival or disease-related symptoms has not been established. Recommended dosing of IMBRUVICA™ for patients with CLL is 420 mg (three 140 mg capsules) orally once daily.

"We're thrilled to continue to support patients who are in need of IMBRUVICA™ and look forward to seeing the impact this therapy will have on the CLL patient population," said Dan Duffy, Chief Business Development Officer at Biologics.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. To send prescriptions via eScribe, physicians may search for Biologics within their EMR system.