Imbruvica wins new CLL approval

28 January 2019

Imbruvica (ibrutinib) clocked up a third US Food and Drug Administration (FDA) approval in first-line chronic lymphocytic leukemia (CLL) on Monday, this time in combination with Gazyva (obinutuzumab).

The Bruton's tyrosine kinase (BTK) inhibitor, which is being jointly developed and commercialized by Janssen, the Rx drug unit of Johnson & Johnson (NYSE: JNJ), and AbbVie (NYSE: ABBV), has now won 10 FDA approvals in six different disease areas, since 2013.

The latest FDA approval expands the use of Imbruvica, which can already be administered as a single agent or in combination with bendamustine and rituximab for adult CLL or small lymphocytic lymphoma.

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