FDA Approves First Breakthrough Therapy – Genentech’s Gazyva(TM)

FDA Approves Gazyva™ (Obinutuzumab) for People With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

  • Gazyva Demonstrated an 84 Percent Reduction in the Risk of Disease Worsening or Death When Combined with Chemotherapy Compared to Chemotherapy Alone
  • Gazyva is the First Medicine Approved with the FDA’s Breakthrough Therapy Designation

South San Francisco, Calif. — November 1, 2013 —

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Gazyva™ (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL). Gazyva (pronounced gah ZY vuh) is the first medicine approved with the FDA’s Breakthrough Therapy Designation and the fifth cancer medicine from Genentech approved by the FDA in the past three years.

Genentech Web“Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as it more than doubled the time people lived without their disease worsening compared to chlorambucil alone,” said Hal Barron, M.D., chief medical officer and head of Global Product Development. “We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers.”

The FDA granted Gazyva Breakthrough Therapy Designation due to the significance of the positive progression-free survival (PFS) results from the Phase III CLL11 trial and the serious and life-threatening nature of CLL.

Today’s FDA approval is based on the outcomes of the CLL11 trial. The trial showed that people who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death (HR=0.16; p<0.0001) and lived significantly longer without their disease getting worse compared to those who received chlorambucil alone (median PFS 23.0 months vs. 11.1 months). The most common Grade 3/4 adverse events for those who received Gazyva in combination with chlorambucil compared to chlorambucil alone were infusion-related reactions during the first infusion (21 percent vs. 0 percent [chlorambucil is an oral medicine]), low platelet count (thrombocytopenia, 11 percent vs. 3 percent) and low count of certain types of white blood cells (neutropenia, 34 percent vs. 16 percent), though this did not result in an increased rate of infections in the Gazyva arm.

Final data from the CLL11 trial investigating the direct comparison between Gazyva in combination with chlorambucil and Rituxan® (rituximab) in combination with chlorambucil (Stage 2) will be presented at the American Society of Hematology’s (ASH) 55th Annual Meeting in December 2013.

Gazyva will be available to people in the United States within approximately two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Gazyva through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at http://www.Genentech-Access.com.

Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Agency (EMA).


Read the full release from Genentech.

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