FDA grants breakthrough therapy designation to venetoclax combo in CLL

20 January 2016  •  Author: Victoria White

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to venetoclax in combination with MabThera/Rituxan (rituximab) for the treatment of people with relapsed or refractory chronic lymphocytic leukaemia (CLL).


Venetoclax is an investigational medicine being developed by Roche in partnership with AbbVie

Venetoclax is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis. It is believed that blocking BCL-2 may restore the signalling system that tells cancer cells to self-destruct. The BCL-2 protein is linked to the development of resistance in certain blood cancers and is expressed in chronic lymphocytic leukaemia (CLL) and non-Hodgkin’s lymphoma (NHL). In collaboration with AbbVie, venetoclax is being evaluated in a development programme as a single agent or in combination with other medicines. There are ongoing Phase II and III studies for venetoclax in CLL, and Phase I and II studies are also ongoing in several other blood cancers, including indolent NHL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukaemia (AML) and multiple myeloma (MM).

Breakthrough therapy designation based on results from M13-365 study

The breakthrough therapy designation was based on results from the M13-365 study. The combination of venetoclax and MabThera/Rituxan for the treatment of people with relapsed or refractory CLL is being further evaluated in the ongoing MURANO (GO28667) study.

Venetoclax was previously granted breakthrough therapy designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.

Commenting on the announcement, Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie, 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. AbbVie will continue harnessing our collective expertise to accelerate efforts to bring new treatment options to patients battling this difficult to treat blood cancer.”

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