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FDA Approves Imbruvica Label Expansion to Include Oral Suspension Formulation


New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation.

Closeup of Cancer cells observed under a microscope. Scientific image cancer medicine chemistry and biology. Ai Generative. Image Credit: Adobe Stock Images/MH STOCK

Image Credit: Adobe Stock Images/MH STOCK

The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1

“As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 patients worldwide have been treated with Imbruvica to date, and we’re continually looking toward the future to help support additional patients,” said Mark Wildgust, PhD, VP, global medical affairs, oncology, Johnson & Johnson Innovative Medicine, in the press release. “The approval of an Imbruvica oral suspension formulation underscores our commitment in providing innovative, alternate delivery options that address individualized patient needs and allow patients flexibility in how they take their medicine.”

Imbruvica was first approved by the FDA in 2013 for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. At the time, it was one of the first medications to receive FDA approval through its Breakthrough Therapy Designation program and was developed as part of the collaboration with Pharmacyclics.2

“The approval of Imbruvica is great news for MCL patients who have received prior therapy and the physicians who treat them,” said William Hait, MD, PhD, global head, research and development, Janssen Research & Development, LLC, in a 2013 press release announcing the approval. “The Breakthrough Therapy Designation helped turbo-charge our timelines—it’s a remarkable process.”

According to J&J, data shows that approximately 5% of patients with a Bruton’s tyrosine kinase inhibitor (BTKi) will find it challenging to swallow. As a result, this new oral suspension formulation is poised to offer a much simpler process for those struggling.1

“Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” said Lisa Nodzon, PhD, ARNP, AOCNP, Moffitt Cancer Center, in the release. “Having multiple formulations of Imbruvica offers prescribers another option when treating adults with CLL/SLL, WM, or cGVHD, which could make a difference in their daily lives.”


1. Johnson & Johnson Announces Expansion of IMBRUVICA® (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications. Johnson & Johnson. February 26, 2024. Accessed February 27, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-expansion-of-imbruvica-ibrutinib-label-in-the-u-s-to-include-oral-suspension-formulation-for-adult-patients-in-its-approved-indications

2. IMBRUVICA™ (ibrutinib) Capsules Now Approved in the U.S. for Mantle Cell Lymphoma Patients Who Have Received at Least One Prior Therapy. Johnson & Johnson. November 13, 2013. Accessed February 27, 2024. https://www.jnj.com/media-center/press-releases/imbruvica-ibrutinib-capsules-now-approved-in-the-us-for-mantle-cell-lymphoma-patients-who-have-received-at-least-one-prior-therapy

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