Janssen and AbbVie's Imbruvica has been cleared by regulators in the US to treat certain patients with marginal zone lymphoma (MZL), a rare form of non-Hodgkin's lymphoma.
The US Food and Drug Administration has granted an accelerated approval to Imbruvica (ibrutinib) for the treatment of patients with relapsed/refractory forms of the disease who require systemic therapy and have received at least one prior anti-CD20-based therapy.
As per the conditions of an accelerated approval, continued clearance may be contingent upon verification and description of clinical benefit in a confirmatory trial, the firms noted.
Approval was based on results of the Phase II, open-label, multi-center, single-arm PCYC-1121 study, which showed that overall response rate was achieved in nearly half (46 percent) of the patients, with efficacy observed across the three MZL sub-types tested.
According to the data, the median time to response was 4.5 months, 3.2 percent of patients had a complete response and 42.9 percent had a partial response, while the drug's safety profile was consistent with the known safety profile of the drug in B-cell malignancies.
Imbruvica is also on the market to treat chronic lymphocytic leukaemia, small lymphocytic lymphoma, mantle cell lymphoma and Waldenström's macroglobulinemia.