FDA Approves New Fixed-Duration Treatment Option for Previously Untreated Chronic Lymphocytic Leukemia
May 15th, 2019
On May 15, 2019, the FDA approved Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
News in brief
- The approval is based on the Phase III CLL14 study, which showed Venclexta plus Gazyva reduced risk of disease progression or death by 67 percent compared to a standard of care in people with untreated CLL.
- People treated with Venclexta plus Gazyva can potentially end treatment and still experience benefit, based on results of the CLL14 study.
- More than 20,000 people in the U.S. will be diagnosed with CLL in 2019, and this combination provides a new chemotherapy-free treatment option for people with CLL who are unable to tolerate standard chemotherapy.
Supporting Information
"Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care. Today’s approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukemia."