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# FDA Approves Imbruvica and Rituximab for Rare Disease
- URL: https://www.fdaweb.com/fda-approves-imbruvica-and-rituximab-for-rare-disease/
- Published: 2018-08-27T12:00:00.000Z
- Updated: 2026-09-15T00:28:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142204

FDA has approved Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) in combination with Genentech’s rituximab for treating Waldenström's macroglobulinemia (WM), a rare blood cancer. Imbruvica first received FDA approval in WM as monotherapy in [1/2015](https://www.jnj.com/media-center/press-releases/us-fda-approves-imbruvica-ibrutinib-for-the-treatment-of-waldenstroms-macroglobulinemia-first-fda-approved-therapy-for-this-disease?ref=fdaweb.com) under the breakthrough therapy designation pathway. This is the ninth FDA approval for Imbruvica, a first-in-class Bruton’s tyrosine kinase inhibitor.

Approval is based on results from the randomized, double-blind, placebo-controlled iNNOVATE study (PCYC-1127), the largest Phase 3 study of a non-chemotherapy combination in WM patients. At a median follow up of 26.5 months, a significant improvement in an independent review committee-assessed primary endpoint of progression-free survival was seen with Imbruvica plus rituximab when compared with placebo plus rituximab (30-month PFS rates were 82% vs. 28%, respectively), the companies say. “Patients in the Imbruvica plus rituximab treatment arm experienced an 80% reduction in relative risk of disease progression or death compared with patients treated with placebo plus rituximab,” they add.