Pharmaceutical Executive February 27, 2024
Don Tracy, Associate Editor

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

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...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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