FDA approves Roche’s Gazyva in follicular lymphoma
pharmafile | February 29, 2016 | News story | Research and Development, Sales and Marketing | Levact, MabThera
Strong Phase III results have seen the US FDA approve Roche’s Gazyva (obinutuzumab) plus Levact (bendamustine) chemotherapy followed by Gazyva alone as a new treatment for people with a common form of non-Hodgkin lymphoma, who did not respond to a MabThera (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.
The US regulator gave its approval, following a priority review, based on results from a Phase III study, which showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy, Gazyva plus bendamustine, followed by Gazyva alone, improved progression-free survival by 52%, compared to bendamustine alone.
“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,” says Sandra Horning, 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.”
With this approval, Gazyva is now approved in the US to treat two common types of blood cancer. The drug is also approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL).
Roche says it has submitted marketing applications for Gazyva – which is manufactured by its subsidiary Genentech – based on the GADOLIN study results have also been submitted to other regulatory authorities, including the EMA, for approval. In Europe, the drug is marketed under the name Gazyvaro.
Joel Levy
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