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Gazyva Wins FDA OK for Untreated Advanced Follicular Lymphoma

In study, progression-free survival was superior to Rituxan-based therapy

Obinutuzumab (Gazyva, Genentech) has won FDA approval for the initial treatment of advanced follicular lymphoma after improving patients’ survival in trials compared with rituximab-based regimens, the current standard of care.

The FDA approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or IV). The approval is based on results from the phase 3 GALLIUM study, which showed superior progression-free survival (PFS) for patients who received this obinutuzumab-based regimen compared with those who received a regimen based on rituximab (Rituxan, Genentech) as a first-line therapy.

Follicular lymphoma, the most common indolent form of non-Hodgkin’s lymphoma (NHL), is incurable and becomes harder to treat each time it returns. Rituximab has been the standard of care in this setting for more than 10 years.

The GALLIUM study showed the obinutuzumab-based regimen significantly reduced the risk of disease worsening or death compared to a rituximab-based regimen by 28% (PFS as assessed by independent review committee; hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.56–0.93; P = 0.0118). The most common grade 3–5 side effects (occurring in at least 5% of patients) observed more frequently in the obinutuzumab arm were low white blood cell count, infusion reactions, low white blood cell count with fever, and low platelet count. The most common side effects (occurring in at least 20% of patients) observed at least 2% more frequently in the obinutuzumab arm included infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea.

GALLIUM (NCT01332968) is a global, open-label, multicenter, randomized two-arm study examining the efficacy and safety of obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to two years, as compared head-to-head against rituximab plus chemotherapy followed by rituximab alone for up to two years. Chemotherapies used (CHOP, CVP or bendamustine) were selected by each participating study site prior to beginning enrollment. GALLIUM included 1,385 patients with previously untreated NHL, of whom 1,202 patients had advanced follicular lymphoma (stage II bulky, III or IV).

Obinutuzumab’s supplemental biologics license application based on the GALLIUM data was granted priority review. With this approval, obinutuzumab is available in the United States for three different indications across two common types of blood cancer: 1) with the chemotherapy drug chlorambucil to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment; 2) with the chemotherapy drug, bendamustine, followed by obinutuzumab alone, for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment; and 3) with chemotherapy, followed by obinutuzumab alone in those who responded, to treat stage II bulky, III or IV FL in adults who have not had previous FL treatment.

Obinutuzumab is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. In the United States, obinutuzumab is part of a collaboration between Genentech and Biogen.

Source: Genentech; November 16, 2017.

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