AbbVie's Rare Blood Cancer Drug Combo Snags FDA Approval

AbbVie Inc ABBV has received FDA approval of its supplemental New Drug Application for Imbruvica to treat a rare type of cancer.

What Happened

AbbVie said its Imbruvica in combination with Roche Holdings AG Basel ADR Common Stock RHHBY's Rituxan has been approved for treating adult patients with Waldenstrom's macroglobulinemia,a rare and incurable type of non-Hodgkin's lymphoma.

Imbruvica, which was first approved as a single-agent therapy for the disease in January 2015, is a Bruton's tyrosine kinase inhibitor jointly developed by AbbVie and Johnson & Johnson JNJ's Janssen Biotech unit.

With this, Imbruvica now has a total of nine FDA approvals across six indications.

The approval is based on an Phase 3 iNNOVATE clinical trial that evaluated the combo versus Rituxan alone. Data from the study showed that patients taking the combo experienced an 80-percent reduction in relative risk of disease progression or death than those treated with Rituxan alone.

Why It's Important

The Imbruvica-Rituxan combo is the first and only chemotherapy-free combination treatment for WM, according to the company.

The approval came about two months earlier than expected. 

"Ibrutinib has significantly advanced the treatment of Waldenström's macroglobulinemia. The approval of ibrutinib and rituximab has added a new option for many Waldenström's patients," Steven Treon, the lead investigator of the Imbruvica Phase 2 clinical trial which served as the basis for its January 2015 FDA approval, said in a statement. 

What's Next

AstraZeneca plc (ADR) AZN is testing its Calquence for the same indication. Calquence has already been approved for mantle cell lymphoma.

AbbVie shares were up 0.46 percent at $97.86 at the time of publication Monday. 

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