Janssen’s Imbruvica Wins Canadian Approval for Chronic Lymphocytic Leukemia
Health Canada has approved Johnson & Johnson subsidiary Janssen’s cancer drug Imbruvica for treating chronic lymphocytic leukemia.
Imbruvica (ibrutinib) was cleared as a first-line treatment for patients with a 17p deletion in a gene that tends to lead to poor treatment outcomes. It also will be indicated as a second-line treatment for patients with all forms of CLL, including those with that deletion.
The approval was based on a Phase III trial evaluating the drug against GlaxoSmithKline’s Arzerra (ofatumumab) that showed Imbruvica generally led to a 78-percent risk reduction of disease progression or death by any cause. It also led to positive outcomes in overall survival, the company said Monday.
Unlike most first-line CLL chemotherapy treatments, Imbruvica can be taken once per day at home and works by blocking a compound that allows affected white blood cells to grow and spread.
The drug should now be available in Canada, said Janssen spokeswoman Kate Hanna. The company is in talks with Health Canada regarding a mantle cell lymphoma indication.
Imbruvica has been approved in Europe for CLL and for mantle cell lymphoma, and in the U.S. as a second-line treatment for most CLL patients and a first-line treatment for those with the 17p deletion. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.