FDA approves first medicine with Breakthrough Therapy designation
Genentech, a member of the Roche Group, has announced that the 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.
“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.
The trial showed people who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death (HR=0.16; p
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.
Gazyva will be available to people in the U.S. within approximately two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Gazyva through Genentech Access Solutions.
Marketing applications also have been submitted to other regulatory authorities, including the European Medicines Agency.