Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for ibrutinib (Imbruvica®), a promising oral therapy, for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).
Mantle cell lymphoma is a rare and aggressive form of B cell lymphoma that grows quickly and often has a poor prognosis. In Canada, close to 500 new cases of MCL are diagnosed each year.
Health Canada has issued marketing authorization with conditions under the NOC/c policy for the treatment of patients with relapsed or refractory MCL to reflect the promising nature of the clinical data. Under this policy, the manufacturer must provide Health Canada with data from additional studies to confirm the clinical benefit of Ibrutinib.
In 2014, Health Canada approved ibrutinib for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) and frontline treatment of CLL patients with the 17p chromosomal deletion.