The FINANCIAL — Roche on February 29 announced that the US Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or had their follicular lymphoma return after such treatment.
Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin lymphoma (NHL) and accounts for approximately one in five cases of NHL, according to Roche.
“People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”
The approval is based on results from the Phase III GADOLIN study, which showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior MabThera®/Rituxan-based therapy, Gazyva/Gazyvaro® plus bendamustine followed by Gazyva/Gazyvaro alone demonstrated a 52 percent reduction (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001) in the risk of disease worsening or death (progression-free survival, PFS), compared to bendamustine alone, as assessed by an independent review committee (IRC). The supplemental Biologics License Application based on these data was granted Priority Review, a designation granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The safety of Gazyva/Gazyvaro was evaluated based on 392 people in the GADOLIN study with indolent NHL of whom 81 percent had follicular lymphoma. The most common Grade 3-4 side effects of this Gazyva/Gazyvaro regimen were low white blood cell counts, infusion reactions and low platelet counts. The most common side effects of this Gazyva/Gazyvaro regimen were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhoea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinus infection, low red blood cell counts, general weakness and urinary tract infection.
With this approval, Gazyva is approved in the United States to treat two common types of blood cancer. Gazyva is also approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) based on data from the pivotal CLL11 study, which compared Gazyva/Gazyvaro plus chlorambucil head-to-head with MabThera/Rituxan plus chlorambucil.
Marketing applications for Gazyva/Gazyvaro based on the GADOLIN study results have also been submitted to other regulatory authorities, including the European Medicines Agency (EMA), for approval consideration.
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