Health Canada has approved Janssen's Imbruvica (ibrutinib) an oral, once-daily, single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukaemia (CLL).

This is the 4th approval for Imbruvica, which now is approved for use in all lines of CLL therapy for patients needing treatment, considerably expanding the number of Canadian patients who may benefit from this chemotherapy-free treatment. Chronic lymphocytic leukaemia is one of the most common types of leukaemia in adults.

The latest approval is based on data from the phase 3 RESONATE-2 (PCYC-1115-CA) study, a head-to-head clinical trial comparing Imbruvica to chlorambucil (a chemotherapy agent). Results showed using Imbruvica first-line was associated with statistically significant improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) compared with chlorambucil treatment.

"The clinical data showed that Imbruvica (ibrutinib) is much more effective than the comparator traditional chemotherapy," says Dr. Carolyn Owen, Associate Professor, Division of Hematology and Hematological Malignancies, Foothills Medical Centre. "Hopefully, this approval will provide an increase in treatment options for patients with CLL that will ensure their disease is well controlled, allowing them to enjoy their life to the fullest."

The expanded Imbruvica indication is based on data from the randomized, international, multi-center, open-label phase 3 RESONATE-2 trial, involving 269 previously untreated patients with CLL aged 65 years or older. It showed Imbruvica significantly improved PFS, OS and ORR versus chlorambucil. At a median follow up of 18.4 months, the PFS, as assessed by an Independent Review Committee (IRC), indicated an 84 per cent statistically significant reduction in the risk of death or progression in the Imbruvica arm versus the chlorambucil arm (HR=0.16 [95 per cent CI, 0.091-0.28]). Median PFS was not reached for Imbruvica versus 18.9 months for chlorambucil (95 per cent CI: 14.1, 22.0). Analysis of OS demonstrated an 84 per cent statistically significant reduction in risk of death for patients in the Imbruvica arm (HR=0.16 [95 per cent CI, 0.048-0.56]). Results also showed a statistically significant improvement in ORR in the Imbruvica arm versus the chlorambucil arm (82 per cent versus 35 per cent, respectively; p<0.0001).  Data from RESONATE-2 were presented in an oral session at the American Society of Hematology (ASH) Annual Meeting on December 7, 2015, in addition to being featured in the official ASH press program and simultaneously published online in  The New England Journal of Medicine.

"We are pleased with the recent approval of Imbruvica by Health Canada," says Shelagh Tippet-Fagyas, president of the leukaemia and Lymphoma Society of Canada. "This approval means broader drug access and options for CLL patients, such as the benefit of earlier chemotherapy-free treatments."

Imbruvica contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread. The recommended dose of Imbruvica for CLL is 420 mg (three 140-mg capsules) orally, once-daily.

Imbruvica is approved in Canada for the treatment of patients with previously untreated active chronic lymphocytic leukaemia (CLL), including those with 17p deletion. It is also approved for the treatment of patients with CLL who have received at least one prior therapy, including those with 17p deletion. Imbruvica is approved for the treatment of patients with Waldenström's macroglobulinemia (WM), and approved (with conditions) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).

Imbruvica is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets Imbruvica in Canada.