Nancy Valente, M.D.VP of Global Hematology DevelopmentGenentech

Genentech Submits New Drug Application to FDA for Venclexta Plus Gazyva for Untreated CLL with Co-Existing Medical Conditions Interview with:

Nancy Valente, M.D.VP of Global Hematology DevelopmentGenentech

Dr. Valente

Nancy Valente, M.D.
VP of Global Hematology Development

Dr. Valenta discusses the announcement of the submission by Genentech of a supplemental New Drug Application to the FDA for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia  with co-existing medical conditions. What is the background for this study?
What are the main findings of the Phase III CLL14 study? 

Response: We completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. CLL is the most common form of adult leukemia and more than 20,000 new cases will be diagnosed in the U.S. this year.

The sNDA is based on data from the Phase III CLL14 study, which evaluated fixed-duration Venclexta in combination with Gazyva in people with previously untreated CLL. Results showed this chemotherapy-free combination can help people with previously untreated CLL live significantly longer without their disease worsening (progression-free survival; PFS) compared to standard-of-care Gazyva plus chlorambucil.

The FDA is reviewing our application under the Real-Time Oncology Review (RTOR) pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. 

Response: How does Venclexta in combination with Gazyva differ from other medications (or combinations) for CLL treatment?

Response: Results from the CLL14 study showed improved clinical outcomes with our novel BCL-2 inhibitor Venclexta plus Gazyva compared to Gazyva plus chlorambucil, a current standard of care. It is important to note that the combination of Venclexta, plus Gazyva is a 12-month fixed-duration and chemotherapy-free. What should readers take away from your report?

Response: These results indicate that Venclexta plus Gazyva could provide a chemotherapy-free, fixed-duration treatment option for people with previously untreated CLL with co-existing medical conditions. Although there have been advances in treatment for people with this disease, many patients cannot tolerate the side effects of standard chemotherapy due to their age or health, so additional treatment options are needed. What future research is ongoing or planned? Is there anything else you would like to add?

Response: We are continuing to investigate both Venclexta in combination with approved and investigational molecules in a robust clinical development program across a range of blood cancers. As a testament to its potential, Venclexta has now been granted five Breakthrough Therapy Designations by the FDA: three in CLL and two in acute myeloid leukemia, or AML.

Combination studies evaluating Gazyva with approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are also underway. 


Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions

Application is being reviewed under FDA’s Real-Time Oncology Review pilot program
Combination was granted Breakthrough Therapy Designation, the fifth for Venclexta
South San Francisco, CA — March 7, 2019

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Last Updated on March 25, 2019 by Marie Benz MD FAAD