FDA to review AbbVie drug to assist marrow transplants
A gruesome potential side effect of stem cell or bone marrow transplants in oncology patients may soon meet its match in AbbVie’s Imbruvica, which has been accepted for review by the FDA for chronic graft-versus-host disease.
The condition occurs when tissue transplanted into a patient rejects the patient’s own body cells, AbbVie said in an April 4 press release. If the drug gets the go-ahead, it will be a unique treatment for the illness, which has traditionally been remedied with steroids.
But as Dr. Lori Styles, senior medical director at AbbVie subsidiary Pharmacyclics LLC, said in the release, steroids sometimes prove ineffective or dangerous for some patients.
“This regulatory filing is meaningful as it signifies the first potential indication for ibrutinib (Imbruvica’s key ingredient) outside of hematological malignancies in a disease that severely impacts the patient's quality of life,” Styles said in the release. “We are pleased that these patients now have the potential for an effective treatment option.”
AbbVie said it noticed Imbruvica’s usefulness with chronic graft-versus-host disease after Phase 1b/2 clinical tests showed positive results in 42 patients who had undergone past treatment for the condition.
The company recently highlighted the outcomes at conferences for both the American Society of Hematology and the Blood and Marrow Transplantation Tandem.
Organizations in this story
AbbVie 1 N Waukegan Rd Lake Bluff, IL 60044
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903