NICE Rejects Janssen's Imbruvica to Treat Waldenstrom's Macroglobulinemia

The UK’s price watchdog is not recommending Janssen’s Imbruvica for the treatment of Waldenstrom's macroglobulinemia, a rare type of non-Hodgkin's lymphoma.

In a draft appraisal, the UK’s National Institute for Health and Care Excellence said there is limited evidence to support Imbruvica’s use as a first-line treatment when chemoimmunotherapy is unsuitable, or subsequent treatment when patients have had at least one prior therapy.

Janssen’s submission to NICE included results from a single open-label trial that enrolled 63 adults with Waldenstrom’s macroglobulinemia who had had at least one prior therapy. The study, however, did not enroll patients for whom chemoimmunotherapy is unsuitable, which NICE deemed a limitation.