EU approves Imbruvica plus rituximab in first-line CLL

This article was originally published by The Pharma Letter

Johnson & Johnson (NYSE: JNJ) and AbbVie (NYSE: ABBV) have secured approval for a broader label for the BTK blocker Imbruvica (ibrutinib) in Europe.

The decision extends the approved indication in chronic lymphocytic leukemia (CLL) to include first-line treatment in combination with the targeted biologic therapy rituximab, and comes months after the US regulator provided approval in the same indication.

The decision is based on data from the Phase III E1912 study, which provides a favorable comparison with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR).

Profitable partnership

First approved in 2013, Chicago-based AbbVie (NYSE: ABBV) is jointly developing and commercializing Imbruvica with J&J’s pharma arm, Janssen.

The firms are in an equal partnership in developing the drug, after AbbVie acquired the original development partner Pharmacyclics for $21 billion in 2015.

The new approval in CLL represents the 11th approval overall for the product, and the sixth approval for Imbruvica in this cancer type.

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