The Ministry of Food and Drug Safety (MFDS) will change approval conditions for Janssen Korea’s leukemia therapy Imbruvica (compound: ibrutinib), in the wake of overseas reports that the drug showed reactivation of hepatitis B virus or HBV.
The ministry reviewed Imbruvica’s safety data released by Germany’s Federal Institute for Drugs and Medical Devices(FIDMD) and said it will reflect it to change approval conditions.
Imbruvica can be applied to indications in mantle cell lymphoma and chronic lymphocytic leukemia.
The federal institute found on July 18 that patients who took treatment with Imbruvica showed the HBV activation. Accordingly, it ordered hospitals to take a test of HBV infection before they treat patients with Imbruvica.
Following the reports, the ministry will add “reactivation of hepatitis B virus” to the warning of side effects.
Imbruvica was approved in August 2014 in Korea and has received medical insurance since June 1, 2016. With 50 percent of Korean patients having the HBV antibody, caution is raised for the HBV reactivation in treatment with Imbruvica.