The company said its treatment outperformed Rituxan (rituximab) for follicular lymphoma, the most common type of slow-growing non-Hodgkin lymphoma.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” Sandra Horning, Roche’s chief medical officer and head of global product development, said in a press release.
The FDA based its decision on data from the ongoing Phase 3 GALLIUM trial (NCT01332968), which showed that Gazyva-treated patients had a 28% lower risk of disease progression or death compared to people treated with Rituxan and chemotherapy.
The study included 1,202 patients with advanced follicular lymphoma — at stages II bulky, III, or IV — where half of the patients were randomly assigned to Gazyva plus chemotherapy. Those who responded to treatment were then treated with Gazyva alone. The other patients, treated with Rituxan plus chemotherapy, received Rituxan as their maintenance therapy.
The results after three years of treatment showed that progression-free survival was better among those treated with Gazyva.
Researchers noted that side effects were slightly more common in the Gazyva group and included reactions to the infusions, low white blood cell counts, upper airway infections, constipation, and diarrhea.
In October, an interim analysis of the trial showed similar assessments of progression-free survival. Gazyva-treated patients had an estimated three-year progression-free survival of 80% compared to 73.3% for those on Rituxan-based therapy. This translated into a 34% lower risk of disease progression or death.
Gazyva, which is sold in Europe under the brand name Gazyvaro, binds to the same protein — CD20, which is present on certain types of B-cells — as Rituxan. The therapy was earlier approved in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL), and with bendamustine for follicular lymphoma patients who failed earlier treatments.
“We’re pleased we can now offer patients with this incurable blood cancer an initial treatment option shown to improve upon Rituxan, the standard of care in this setting for more than 10 years,” Horning said.