US FDA approves Roche’s leukaemia treatment

A leukaemia treatment developed by Roche has been granted approval by regulators in the US.

The pharmaceutical company has developed Gazyva (obinutuzumab) as a treatment for follicular lymphoma patients who did not respond to a Rituxan (rituximab)-containing regimen, or had their follicular lymphoma return after such treatment. 

The drug has already been marketed as a treatment for chronic lymphocytic leukaemia in both the US and Europe.

However, this latest decision by the US Food and Drug Administration broadens the potential market for Gazyva (obinutuzumab) considerably.

Sandra Horning, head of global product development at Roche, commented: "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."

The approval also comes at a time of growing competition in this segment of the market, as  Johnson & Johnson's first-in-class BTK inhibitor Imbruvica (ibrutinib) and Gilead Sciences' Zydelig (idelalisib) have recently been launched as treatment options for follicular lymphoma patients.