Health Canada granted approval for Imbruvica (ibrutinib), as an oral, once-daily, single-agent therapy for the treatment of patients with Waldenström’s macroglobulinemia. This approval was based on an investigator-led, multicenter, prospective, single-arm study in 63 patients who had received at least one prior therapy. The results of the study were published in the New England Journal...
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
