FDA Endorses first Treatment for Chronic Graft Versus Host Disease

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In a recent industry development, the FDA has extended the approval of Imbruvica for the treatment of chronic graft versus host disease (cGVHD). The therapy is the first to receive FDA approval for the treatment of cGVHD. As a result, patients now have a treatment option who do not respond to other forms of therapy, which typically includes corticosteroids to suppress the immune system. As stated by an FDA executive, the development highlights how a known treatment for cancer has received approval for treating a life-threatening condition.

cGVHD is a serious condition that may occur in patients with blood cancer after undergoing hematopoietic stem cell transplantation (HSCT). HSCT involves stem cell transplant from blood or bone marrow to treat some forms of blood or bone marrow cancers. cGVHD happens when transplanted stem cells attack healthy tissues in the patient’s body. The symptoms of cGVHD can develop in the skin, eyes, gut, liver, mouth, and lungs. The condition happens in 30-70% of patients who receive HSCT.

Considerable Duration of Decline of Disease Symptoms Endorses Drug Efficacy

To determine the efficacy and safety of Imbruvica, 42 patients whose symptoms of cGVHD persisted despite administering alternate therapies, were studied in a single-arm trial. Symptoms in most patients included mouth ulcers and skin rashes, with more than 50 percent patients having two or more organs. Following the trial, 67 percent of patients showed improvement in their cGVHD symptoms. Among them, 48 percent of patients showed improvement in symptoms for five months or longer. Some of the side effects of Imbruvica include fatigue, diarrhea, bruising, muscle spasms, and low blood platelet level.

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