A combination of AbbVie Inc.'s Venclexta and Roche Holding AG's Rituxan gained the U.S. Food and Drug Administration's approval to treat patients with a certain type of blood cancer regardless of a particular genetic mutation.
The regulator approved the combination therapy to treat patients with chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, who have received at least one prior therapy. The treatment can be used regardless of the 17p deletion, in which the absence of the upper part of chromosome 17 makes the body lose its ability to prevent and control malignant cells.
CLL is a slow-progressing cancer that affects certain white blood cells in bone marrow and blood, and SLL is characterized by the presence of cancer cells in the lymph nodes and spleen.
The approval is based on a phase 3 study, called Murano, in which the combination reduced the risk of the growth in cancer or death by 81% compared to the standard chemoimmunotherapy regimen of Rituxan and Teva Pharmaceutical Industries Ltd.'s Treanda, or bendamustine.
The companies said Venclexta plus Rituxan is the first oral, chemotherapy-free combination to treat CLL that gives patients a choice to get treatment for a fixed duration, which can be about two years.
The U.S. FDA approved Venclexta in April 2016 as a stand-alone treatment for patients with CLL with 17p deletion who have received at least one prior therapy. The FDA also expanded the drug's usage, approving it for second-line treatment of CLL or SLL patients, regardless of 17p deletion.
AbbVie is also testing a combination of Venclexta and Imbruvica, which it co-markets with Johnson & Johnson, for first-line treatment of patients with CLL or SLL.
