publication date: Jul. 22, 2016

Drugs and Targets

Health Canada Approves Imbruvica in Untreated CLL


Health Canada approved Imbruvica (ibrutinib) as an oral, once-daily, single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukemia. This is the fourth Canadian approval for Imbruvica, which is now approved for use in all lines of CLL therapy.

The approval is based on data from the phase III RESONATE-2 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, overall survival and overall response rate compared with chlorambucil treatment.

Data from RESONATE-2 were presented in an oral session at the annual meeting of the American Society of Hematology in December 2015, and was published in The New England Journal of Medicine.

Imbruvica is approved in Canada for the treatment of patients with previously untreated active chronic lymphocytic leukemia, including those with 17p deletion, as well as those who have received at least one prior therapy. Imbruvica is also approved for the treatment of patients with Waldenström’s macroglobulinemia, and approved with conditions for relapsed or refractory mantle cell lymphoma.

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.


Kisplyx (lenvatinib), in combination with everolimus, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor targeted therapy.

The opinion was based on results from a phase II trial that showed lenvatinib plus everolimus significantly extends progression-free survival in patients with unresectable advanced renal … Continue reading 42-29 Health Canada Approves Imbruvica in Untreated CLL

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