FDA Expands the Use of Ibrutinib to Include Combination for Certain Patients With CLL/SLL – APhA submits compounding comments to FDA.

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FDA Expands the Use of Ibrutinib to Include Combination for Certain Patients With CLL/SLL – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has approved the use of ibrutinib (Imbruvica®, AbbVie) in combination with obinutuzumab (Gazyva®) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This approval expands the use of ibrutinib, which can also be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients.

The approved ibrutinib therapy is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally. It is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

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