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

Apr 13
Apr 13, 2023

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 Since 2020, more than 20 oncology indications and/or drugs approved through the accelerated pathway have been withdrawn. Read more
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.