FDA Approves Easier-to-Swallow Imbruvica Formulation

The Food and Drug Administration (FDA) approved a label expansion for Imbruvica (ibrutinib), now making the drug more accessible to patients who have difficulty swallowing, according to a press release from Johnson & Johnson, one of the co-manufacturers of Imbruvica.

Specifically, the FDA OKed an oral suspension formulation of Imbruvica for all of its approved indications: the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); patients with Waldenström’s macroglobulinemia; and for patients who have chronic graft-versus-host disease (cGVHD) who underwent at least one prior line of therapy.

When a medication has an oral suspension formulation, the drug is dissolved in a liquid to make it easier to swallow than a pill or tablet. According to a review published in the journal Current Drug Delivery, “An oral pharmaceutical suspension has been one of the most favorable dosage forms for pediatric and geriatric patients or patients unable to tolerate solid dosage forms. The liquid form is preferred because of the ease of swallowing and flexibility in the administration of doses.”

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Imbruvica is a BTK inhibitor that works by inhibiting a certain protein that contributes to cancer cells’ growth, according to the National Institutes of Health. While Imbruvica was the first BTK inhibitor to be FDA-approved, other drugs with the same mechanism of action — such as Calquence (acalabrutinib) and Venclexta (venetoclax) — have since followed suit. In a 2022 interview with CURE®, one expert said that these types of drugs are a “godsend” for certain patients.

However, the press release from Johnson & Johnson noted that approximately 5% of patients with CLL or Waldenström’s macroglobulinemia being treated with a BTK inhibitor experience difficulty swallowing, highlighting a need for a better way to deliver the medications.

“Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” Lisa Nodzon, an oncology nurse practitioner at Moffitt Cancer Center, said in the press release. “Having multiple formulations of Imbruvica offers prescribers another option when treating adults with CLL/SLL, [Waldenström’s macroglobulinemia] or cGVHD, which could make a difference in their daily lives.”

Imbruvica was first approved by the FDA in November 2013 for mantle cell lymphoma. Other indications the drug has been approved in include:

• March 2016: Single-agent Imbruvica for the frontline treatment of CLL
• August 2017: Single-agent Imbruvica for cGVHD
• August 2018: Imbruvica plus Rituxan for Waldenström macroglobulinemia
• January 2019: Imbruvica plus Gazyva for frontline CLL/SLL
• August 2022: Single-agent Imbruvica for children aged 1 and older with cGVHD

“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,” Mark Wildgust, vice president, Global Medical Affairs, Oncology, Johnson & Johnson Innovative Medicine, said 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.”

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