FDA News

FDA grants priority review to Gazyva for previously untreated follicular lymphoma

The FDA granted priority review to obinutuzumab for patients with previously untreated follicular lymphoma, according to the drug’s manufacturer.

Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody that attacks tumor cells directly and with the immune system.

The FDA previously approved obinutuzumab in combination with bendamustine for adults with follicular lymphoma who did not respond to a rituximab (Rituxan; Genentech, Biogen)-containing regimen, or whose disease returned after such treatment. Obinutuzumab also is approved for use with chlorambucil for adults with untreated chronic lymphocytic leukemia.

The agency based the new priority review designation on data from the randomized phase 3 GALLIUM study, designed to compare the efficacy and safety of obinutuzumab with rituximab in 1,401 patients with previously untreated indolent non-Hodgkin’s lymphoma, most (n = 1,202) of whom had follicular lymphoma.

Researchers randomly assigned patients to obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years, or to rituximab plus chemotherapy followed by rituximab alone for up to 2 years.

Investigator-assessed PFS served as the primary endpoint. Secondary endpoints included PFS assessed by independent review committee, PFS in the overall study population, overall response rate, OS and safety.

After 41.1 months of follow-up, patients treated with obinutuzumab demonstrated a 32% reduced risk for disease worsening or death compared with patients treated with rituximab (HR = 0.68; 95% CI, 0.54-0.87).

Independent review committee-assessed PFS appeared consistent with investigator-assessed PFS, showing a 28% reduction in risk for disease worsening or death in the obinutuzumab group (HR = 0.72; 95% CI, 0.56-0.93).

The most common grade 3 to grade 5 adverse events that occurred more frequently in the obinutuzumab group were low white blood cell count (46.7% vs. 39.5%), infections (20.3% vs. 16.4%), infusion-related reactions (12.4% vs. 6.7%), low platelet count (6.1% vs. 2.7%), second malignancies (4.7% vs. 2.7%) and cardiac events (3.9% vs. 2.8%).

“Follicular lymphoma becomes harder to treat each time it returns, and the goal of initial treatment is to prevent the cancer from progressing for as long as possible,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “Based on the GALLIUM study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible.”

The FDA is scheduled to make a decision on this indication by Dec. 23.

The FDA granted priority review to obinutuzumab for patients with previously untreated follicular lymphoma, according to the drug’s manufacturer.

Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody that attacks tumor cells directly and with the immune system.

The FDA previously approved obinutuzumab in combination with bendamustine for adults with follicular lymphoma who did not respond to a rituximab (Rituxan; Genentech, Biogen)-containing regimen, or whose disease returned after such treatment. Obinutuzumab also is approved for use with chlorambucil for adults with untreated chronic lymphocytic leukemia.

The agency based the new priority review designation on data from the randomized phase 3 GALLIUM study, designed to compare the efficacy and safety of obinutuzumab with rituximab in 1,401 patients with previously untreated indolent non-Hodgkin’s lymphoma, most (n = 1,202) of whom had follicular lymphoma.

Researchers randomly assigned patients to obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years, or to rituximab plus chemotherapy followed by rituximab alone for up to 2 years.

Investigator-assessed PFS served as the primary endpoint. Secondary endpoints included PFS assessed by independent review committee, PFS in the overall study population, overall response rate, OS and safety.

After 41.1 months of follow-up, patients treated with obinutuzumab demonstrated a 32% reduced risk for disease worsening or death compared with patients treated with rituximab (HR = 0.68; 95% CI, 0.54-0.87).

Independent review committee-assessed PFS appeared consistent with investigator-assessed PFS, showing a 28% reduction in risk for disease worsening or death in the obinutuzumab group (HR = 0.72; 95% CI, 0.56-0.93).

The most common grade 3 to grade 5 adverse events that occurred more frequently in the obinutuzumab group were low white blood cell count (46.7% vs. 39.5%), infections (20.3% vs. 16.4%), infusion-related reactions (12.4% vs. 6.7%), low platelet count (6.1% vs. 2.7%), second malignancies (4.7% vs. 2.7%) and cardiac events (3.9% vs. 2.8%).

“Follicular lymphoma becomes harder to treat each time it returns, and the goal of initial treatment is to prevent the cancer from progressing for as long as possible,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “Based on the GALLIUM study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible.”

The FDA is scheduled to make a decision on this indication by Dec. 23.