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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.