AbbVie Gets FDA Priority Review for Imbruvica/Rituximab Combo

   By Colin Kellaher 
 

AbbVie Inc. (ABBV) on Monday said the Food and Drug Administration accepted for priority review a supplemental New Drug Application for Imbruvica in combination with rituximab as a new treatment option for an incurable form of blood cancer.

The North Chicago., Ill., biopharmaceutical company said the sNDA, if approved, would expand the FDA's prescribing information for Imbruvica in Waldenstrom's macroglobulinemia, or WM, as the first chemotherapy-free combination treatment option.

AbbVie said the filing is based on data from a Phase 3 study that suggests Imbruvica plus rituximab may improve outcomes across all lines of WM treatment, including patients with prior lines of therapy and various genetic factors, versus rituximab alone. Roche Holding AG (ROG.EB) markets rituximab under the name Rituxan.

Imbruvica, a cancer drug jointly developed and commercialized by units of AbbVie and Johnson & Johnson (JNJ), is currently approved for use as a single agent in WM, a rare and incurable form of non-Hodgkin's lymphoma.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

June 25, 2018 09:49 ET (13:49 GMT)

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