Biopharmaceutical firm AbbVie has received breakthrough therapy status from the US Food and Drug Administration (FDA) for its venetoclax in combination with rituximab to treat patients with relapsed / refractory chronic lymphocytic leukemia (R/R CLL).

Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein, which is being developed by AbbVie in collaboration with Genentech and Roche.

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The FDA has provided the designation based on the results of an investigational study of venetoclax in combination with rituximab in patients with R/R CLL.

Rituximab is indicated in combination with fludarabine and cyclophosphamide to treat patients with previously untreated and previously treated CD20-positive CLL.

"AbbVie will continue harnessing our collective expertise to accelerate efforts for bringing new treatment options to patients battling this difficult-to-treat blood cancer."

According to the company, Rituximab in combination with the investigational agent venetoclax has not yet received approval for the treatment of R/R CLL.

AbbVie research and development executive vice president and chief scientific officer Dr Michael Severino said: "This second breakthrough therapy designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating relapsed / refractory CLL patients, and reflects AbbVie’s commitment to providing breakthrough therapies for cancer patients.

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"AbbVie will continue harnessing our collective expertise to accelerate efforts for bringing new treatment options to patients battling this difficult-to-treat blood cancer."

Last April, the FDA granted breakthrough therapy status to single agent venetoclax for the treatment of CLL in previously treated (relapsed / refractory) patients with the 17p deletion genetic mutation.

Currently, Venetoclax is being assessed for the treatment of patients with various cancer types.

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