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.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.