The US Food and Drug Administration (FDA) has approved Roche's new drug Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for treatment of patients with chronic lymphocytic leukemia (CLL) who have not previously been treated.
Gazyva is a new monoclonal antibody designed to attach to CD20, a protein found only on B-cells, and it works by helping certain immune system cells to attack cancer cells.
The drug is claimed to be the first to receive the FDA's breakthrough therapy status, which is based on positive progression-free survival (PFS) results from the Phase III CLL11 trial.
Roche chief medical officer and head of Global Product Development Hal Barron said, "Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as based on clinical data, it more than doubled the time people lived without their disease worsening compared to chlorambucil alone."
The CLL11 trial demonstrated that people who were given Gazyva in combination with chlorambucil chemotherapy had reduced risk of disease progression or death and lived longer without their disease getting worse compared to those who received chlorambucil alone.
The most common Grade 3/4 adverse events for the patients who were given the combination drug compared to chlorambucil alone were infusion-related reactions during the first infusion, low platelet count and low count of certain types of white blood cells.
According to the company, the combination drug did not result in an increased rate of infections in the Gazyva arm.
Roche has also submitted marketing applications of the drug to other regulatory authorities, including the European Medicines Agency (EMA).
The company said that the final data secured from the CLL11 trial assessing the direct comparison between Gazyva in combination with chlorambucil and MabThera/Rituxan (rituximab) in combination with chlorambucil (Stage 2), will be released in December 2013.
