Gazyva (obinutuzumab) is a monoclonal antibody developed by Roche to treat people with follicular lymphoma, the most common type of slow-growing non-Hodgkin’s lymphoma. It is used in combination with the chemotherapy drug bendamustine to bring cancer into remission, and then it is used alone to keep cancer from returning.

Gazyva is approved to treat people who either did not respond to Rituxan (rituximab) or had their cancer return after Rituxan treatment.

How Gazyva works

Gazyva is an antibody against a protein called CD20 that is present on the surface of lymphoma cells. It fights lymphoma directly when it binds to CD20, an event that destroys the cancer cell. Gaszyva also helps the patient’s immune system seek out and destroy cancer cells.

Gazyva in clinical trials

Gazyva was approved in mid-2016, in both the U.S. and Europe, to treat follicular lymphoma that had not responded to other treatments. This approval was based on the results of an open-label Phase 3 study (NCT01059630) called GADOLIN.

The GADOLIN study included 396 patients who had not improved after treatment with standard of care therapy that included Rituxan. Participants were randomized to receive either Gazyva plus bendamustine followed by Gazyva maintenance therapy, or bendamustine therapy alone. The results, published in August 2016 in the medical journal The Lancet Oncology, showed that treatment with Gazyva was more effective than bendamustine therapy alone, and had a reasonable safety profile.

On Aug. 28, 2017, Roche announced that the U.S. Food and Drug Administration (FDA) had granted Gazyva priority review status for treating patients with follicular lymphoma who never had been treated with any chemotherapy drug. This action was based on the results of an additional open-label Phase 3 trial (NCT01332968) called GALLIUM.

The GALLIUM study included 1,202 patients with follicular lymphoma who had not been treated previously. Participants received either Gazyva plus chemotherapy, followed by up to two years of Gazyva alone, or Rituxan plus chemotherapy, followed by Rituxan alone. The study showed that 34.5 months after starting treatment, patients treated with a Gazyva-based therapy had a 28% lower risk of their cancer worsening, or dying, compared to patients on Rituxan-based therapy. Severe adverse events were more common in patients treated with Gazyva-based therapy than those treated with Rituxan-based therapy.

Based on these results, in November 2017, the FDA approved Gazyva in combination with chemotherapy, followed by Gazyva alone in patients with advanced follicular lymphoma who had not been treated before.

An open-label Phase 1 study (NCT00825149) called GAUDI, completed in November 2015, had shown that Gazyva had an acceptable safety profile, leading investigators to conclude that it showed promise as an effective treatment for non-Hodgkin’s lymphoma. The results of this study supported the advancement of Gazyva into Phase 3 trials.

Additional information

Gazyva is administered as an infusion over the course of several hours. The most common side effects of the treatment are related to the infusion itself. The treatment is not suitable for those who have hepatitis B.

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