The Food and Drug Administration (FDA) today approved Roche/Genentech’s obinutuzumab (Gazyva), also known as GA101, for untreated Chronic Lymphocytic Leukemia (CLL) in combination with the chemotherapy chlorambucil. Updated CLL11 trial data will be presented at the 2013 annual meeting of the American Society of Hematology (twitter #ASH13) in New Orleans from December 7-10. Gazyva is the first drug with a Breakthrough Therapy Designation to be approved by the FDA.

“Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as it more than doubled the time a person lived without their disease worsening compared to chlorambucil alone,” said Hal Barron, M.D., chief medical officer and head of Global Product Development in a press release this morning.

Blog readers who attended the Roche analyst event in Chicago during the ASCO annual meeting in June will have noted that Roche’s long-term corporate strategy is focused on combining cancer drugs to improve treatment outcomes; a theme echoed by Charles Sawyers, President of the American Association for Cancer Research (AACR) during his ASCO Science of Oncology award lecture on “Overcoming Resistance to Cancer Drug Therapy“.

One of the combinations that Roche COO Daniel O’Day highlighted in the analyst event at ASCO was obinutuzumab/GA101 (Gazyva) with GDC-0199 (ABT-199) for the treatment of B-cell hematological malignancies such as CLL & non Hodgkin’s lymphoma (NHL). Obinutuzumab is a glyco-engineered CD20 antibody, while GDC-0199 is a Bcl-2 inhibitor. Both cause apoptosis (cell death) through complementary mechanisms of action.

An abstract on the preclinical data for this combination will be presented at the ASH annual meeting in New Orleans. A phase 1 clinical trial in CLL with this combination is currently underway and recruiting patients (NCT01685892).

I had the great pleasure at the recent AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics meeting in Boston to talk with Deepak Sampath, PhD the leader of Genentech’s Bcl-2 preclinical research about the rational for the obinutuzumab plus GDC-0199 combination.

What he said during the interview makes for interesting reading, and suggests this combo could have blockbuster potential!

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