FDA expands approval of Johnson & Johnson/Pharmacyclics' Imbruvica to Waldenstrom’s macroglobulinemia

30 January 2015

The US Food and Drug Administration has expanded approval of Johnson & Johnson (NYSE: JNJ) and Pharmacyclics’ (Nasdaq: PCYC) Imbruvica (ibrutinib) to include the treatment of Waldenstrom’s macroglobulinemia.

This approval makes it the first drug authorized to treat the condition. The FDA’s decision was supported by data from a Phase II study of 63 patients with previously-treated Waldenstrom’s macroglobulinemia, where the therapy was associated with a 62% response rate.

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