FDA Approves Generic Ibrutinib Tablets for B-Cell Malignancies

FDA

The FDA has granted tentative approval to a generic tablet formuatlion of ibrutinib (Imbruvica) for the treatment of select patients with B-cell malignancies.1

The approval includes tablets at dosages of 140 mg, 280 mg, and 420 mg, mirroring the approved tablets for the reference medication.1,2 The generic formulation is produced by Zydus Lifesciences.1

The BTK inhibitor is currently indicated for the treatment of the following patient populations:2

• Adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
• Adult patients with CLL/SLL harboring a 17p deletion
• Adult patients with Waldenström macroglobulinemia
• Adult and pediatric patients 1 year of age and older with chronic graft vs host disease (cGVHD) after progression on 1 or more lines of systemic therapy

For patients with CLL, SLL, or Waldenström macroglobulinemia, ibrutinib is indicated at a dose of 420 mg once daily. For patients with cGVHD, ibrutinib is indicated at 420 mg once per day in those 12 years of age and older. For patients 1 year to less than 12 years of age, the BTK inhibitor is intended to be dosed at 240 mg/m2 once per day, with a maximum dose of 420 mg.

Notably, indications for ibrutinib for the treatment of patients with mantle cell lymphoma who have previously received at least 1 therapy and those with marginal zone lymphoma who require systemic treatment and have received at least 1 prior anti–CD20-based therapy were voluntarily withdrawn in 2023.3

References

1. Zydus receives tentative approval from USFDA for Ibrutinib tablets 140 mg, 280 mg, and 420 mg. News release. Zydus Lifesciences. July 24, 2025. Accessed July 24, 2025. https://www.zyduslife.com/investor/admin/uploads/21/83/Zydus-receives-tentative-approval-from-USFDA-for-Ibrutinib-tablets-140-mg--280-mg--and-420-mg.pdf
2. Imbruvica. Prescribing information. AbbVie. December 2024. Accessed July 24, 2025. https://www.rxabbvie.com/pdf/imbruvica_pi.pdf
3. Update on Imbruvica (ibrutinib) US accelerated approvals for mantle cell lymphoma and marginal zone lymphoma indications. News release. AbbVie. April 6, 2023. Accessed July 24, 2025. https://news.abbvie.com/2023-04-06-Update-on-IMBRUVICA-R-ibrutinib-U-S-Accelerated-Approvals-for-Mantle-Cell-Lymphoma-and-Marginal-Zone-Lymphoma-Indications