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# 2 Imbruvica Accelerated Approvals Withdrawn
- URL: https://www.fdaweb.com/2-imbruvica-accelerated-approvals-withdrawn/
- Published: 2023-12-17T12:00:00.000Z
- Updated: 2026-09-14T14:18:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156006

*Federal Register* notice: FDA is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for Pharmacyclics Imbruvica (ibrutinib) capsules and tablets that were approved, respectively, under NDAs 205552 and 210563\. The action follows the company’s decision earlier this year to voluntarily withdraw the two accelerated approval indications after FDA determined that required confirmatory studies could not support conversion to full approval.

“The Phase 3 SHINE study met its primary endpoint and demonstrated a significant progression-free survival advantage in patients with previously untreated MCL but did not show an overall survival advantage,” the company said in April. “The addition of Imbruvica to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm.” Meanwhile, in the Phase 3 SELENE study, the therapy did not meet its primary endpoint of progression-free survival in patients with MZL.

The withdrawal decisions do not affect other approved indications for Imbruvica, according to the company. The therapy was first approved 11/2013, and today it is indicated for adult patients in four disease areas, including three hematologic cancers. These include indications to treat adults with chronic lymphocytic leukemia/small lymphocytic lymphoma; adults with Waldenström’s macroglobulinemia; and adult and pediatric patients aged one year and older with previously treated chronic graft-versus-host disease.

To view the notice, click [here](https://public-inspection.federalregister.gov/2023-27662.pdf?ref=fdaweb.com).