Fifth Indication for Imbruvica
January 19, 2017 – The U.S. FDA granted accelerated approval, based on results from phase 2 studies, for Imbruvica® (ibrutinib), manufactured by AbbVie. Imbruvica is indicated to treat relapsed or recurring marginal zone lymphoma (MZL). A form of non-Hodgkin’s lymphoma, MZL is estimated to affect fewer than 1,000 Americans, mostly older adults. Eligible patients will need to have systemic treatment if they previously have been treated with an anti-CD20 drug, such as Rituxan® (rituximab – Biogen / Genentech). Imbruvica is an oral Bruton’s tyrosine kinase inhibitor which had prior approval for treating certain patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM). It is supplied as 140mg oral capsules. Depending on the condition being treated, either three capsules (420mg) or four capsules (560mg) are taken once a day.
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 U.S. 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 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.