FDA Grants Accelerated Approval to Imbruvica in Marginal Zone Lymphoma

The FDA granted its seventh approval and fifth indication to the cancer drug Imbruvica, for patients with relapsed or refractory marginal zone lymphoma, a rare type of non-Hodgkin’s lymphoma.

The agency granted an accelerated approval based on improvements in overall response rate seen in a Phase II, single-arm, open-label clinical trial of 63 patients. Continued approval may depend on future confirmatory trials. Imbruvica (ibrutinib) is jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.

Imbruvica was previously approved in other non-Hodgkin’s lymphomas, including chronic lymphocytic leukemia, small lymphocytic lymphoma, and others.