News Briefs: J&J, AbbVie Units Will Withdraw Two Imbruvica Indications

The Janssen Pharmaceutical Companies of Johnson & Johnson and AbbVie Inc. unit Pharmacyclics LLC are voluntarily withdrawing two indications for Imbruvica (ibrutinib) that had accelerated approval, the companies said on April 6. Following consultation with the FDA, the companies will remove two non-Hodgkin’s lymphoma indications from the drug’s label: the treatment of people with mantle cell lymphoma (MCL) who have received at least one prior therapy, and the treatment of marginal zone lymphoma (MZL) in people who require systemic therapy and have received at least one anti-CD20-based therapy. The decision follows discussion of the results of two Phase III studies — SHINE for MCL and SELENE for MZL — with the FDA, which “advised that the primary outcomes…were considered insufficient to support conversion to full approval.” The Bruton’s tyrosine kinase inhibitor’s other FDA-approved indications, which comprise four disease areas, including three hematologic cancers, are not impacted. The agency first approved the drug on Nov. 13, 2013, when it granted accelerated approval for the MCL indication. It gave accelerated approval for MZL use on Jan. 19, 2017. Since 2020, more than 20 oncology indications and/or drugs approved through the accelerated pathway have been withdrawn.

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