Positive phase 3 for Genentech’s leukemia drug
Following the US FDA approval of Genentech’s Gazyva, phase 3 clinical trial results have been published showing that the drug helped patients with chronic lymphocytic leukemia live significantly longer without their disease worsening compared to Rituxan.
For patients in the Gazyva arm, median progression-free survival (PFS) was 26.7 months compared with 15.2 months for those in the MabThera / Rituxan arm.
“Gazyva is the result of years of research for patients with chronic lymphocytic leukemia. These new data are important because they showed for the first time that Gazyva significantly extended progression-free survival when directly compared against MabThera / Rituxan.”
Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development.
The data have been accepted for presentation during the Plenary Scientific Session of the 55th Annual Meeting of American Society of Hematology (Abstract #6).
Genentech, which is a member of the Roche Group, has also submitted Marketing Authorisation Applications to other regulatory authorities around the world, including the European Medicines Agency (EMA).
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