AbbVie announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL).
The designation is based on data from an investigational study of venetoclax in combination with rituximab in patients with R/R CLL.
RELATED: FDA Grants Venetoclax NDA Priority Review for CLL
This is the second Breakthrough Therapy designation granted for venetoclax. In April 2015, the FDA granted the first designation to single agent venetoclax for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. The single agent NDA application also received priority review recently.
Venetoclax is an investigational, oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated, in collaboration with Genentech and Roche, for the treatment of various cancer types.
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