The FDA's Approval of Gazyva for Follicular Lymphoma

At least 20% of all patients in the study groups were reported to experience mild infusion reactions, to include low white blood cell count, upper respiratory infections, cough, and constipation or diarrhea.

In the Gazyva group, these side effects occurred “at least 2% more frequently.”

Additionally, “a higher incidence of fatal adverse events and about a 4% higher non-lymphoma mortality was observed in the obinutuzumab (Gazyva) group, predominantly in patients receiving bendamustine.

Nineteen patient deaths (5.6%)occurred with the Gazyva-bendamustine combo. Fifteen bendamustine-induced deaths (4.4%) occurred with the Retuxan combo. (Medscape)

“Because the deaths were relatively the same (for both drugs), the superior progression-free- survival of Gazyva makes it worth having,” said research lead investigator, Robert E. Marcus, M.D. (Medscape)