Imbruvica Labeling Expands
May 9, 2016 – The U.S. Food and Drug Administration (FDA) approved a new indication for Imbruvica® (ibrutinib), manufactured by AbbVie and Janssen Biotech. Imbruvica can include an additional indication for treating Small Lymphocytic Lymphoma (SLL) on results from two clinical trials. It already had FDA approvals for treating Mantle Cell Lymphoma (MCL) and Waldenström’s Macroglobulinemia. In March, Imbruvica received a new indication as initial therapy for patients with Chronic Lymphocytic Leukemia (CLL). Additionally, in combination with bendamustine and rituximab, Imbruvica can be used, after one or more previous treatments, for patients where CLL or SLL either came back or did not respond to previous therapy. Imbruvica, an oral Bruton’s tyrosine kinase inhibitor, is taken once a day at varying doses depending on the condition being treated.
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.