Posted from: Thursday, April 07, 2016 - 12:00 PM - Present

Imbruvica Approved for First-Line CLL

March 4, 2016 – The U.S. Food and Drug Administration granted approval to Imbruvica (ibrutinib), for treatment-naïve patients with chronic lymphocytic leukemia (CLL). Manufactured by Pharmacyclics and Janssen Biotech, Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor, which was first approved in November 2013 for the treatment of relapsed mantle cell lymphoma (MCL). Imbruvica is also indicated for previously -treated CLL; patients who have CLL with 17p deletion, and Waldenstrom’s macroglobulinemia (WM). It is recommended that Inbruvica be taken orally, once daily as three 140mg capsules (420mg total dose) for CLL and WM or four capsules (560mg total) for MCL.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Thursday, December 07, 2017 - 02:44 PM.