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January 20, 2016

AbbVie’s venetoclax-rituximab combination gets FDA breakthrough therapy status to treat R/R CLL

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).

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.

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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