Posted from: Tuesday, September 05, 2017 - 04:08 PM - Present

New Indication for Imbruvica

August 2, 2017 – The U.S. FDA has approved a new indication for Imbruvica® (ibrutinib), manufactured by Pharmacyclics, to treat adults with chronic graft-versus-host disease (cGvHD). Imbruvica is a Bruton’s tyrosine kinase inhibitor, and the first drug indicated to treat cGvHD. Graft-versus-host-disease (GvHD) occurs in 30-70% of patients who receive stem cell transplants from a donor, and arises when the donated tissue (graft) attacks the tissues of the transplant recipient (host) as foreign material. GvHD can typically be controlled with corticosteroids, but some patients develop the chronic form, cGvHD, which does not resolve with corticosteroid treatment.

Almost half of cGvHD patients who received Imbruvica in a clinical trial responded to the treatment for a minimum of five months. The recommended dosage is three 140mg capsules once a day until the patient’s cancer returns, the cGvHD worsens, or the patient is unable to tolerate Imbruvica treatment.

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.

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.


Last Updated Thursday, October 17, 2019 - 09:10 PM.