EU Committee for Medicinal Products for Human Use (CHMP) recommends Gazyvaro (obinutuzumab) plus chemotherapy, followed by Gazyvaro maintenance as a new treatment option for previously untreated advanced follicular lymphoma- Roche

Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro (obinutuzumab) in combination with chemotherapy, followed by obinutuzumab maintenance in people achieving a response, as a new treatment option for previously untreated advanced follicular lymphoma. The CHMP’s recommendation is based on results from the phase III GALLIUM study.

Follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma, is considered incurable, and most people relapse repeatedly. Based on this positive CHMP recommendation, a final decision regarding the approval of obinutuzumab is expected from the European Commission in the near future.

The GALLIUM study is the first phase III study in previously untreated follicular lymphoma to show superior PFS over MabThera/Rituxan (rituximab)-based treatment, the current standard of care. Results showed that obinutuzumab-based treatment reduced the risk of disease progression or death (progression-free survival; PFS), as evaluated by investigator assessment, by 34% (HR=0.66; 95% CI 0.51-0.85, p=0.001) compared to rituximab-based treatment. As supported by an independent review committee (IRC), the risk of disease progression or death was reduced by 29% (HR=0.71; 95% CI 0.54-0.93, p=0.014) compared to rituximab-based treatment. Median PFS has not yet been reached in either treatment arm. Investigator assessment showed that at three years, 80.0% of patients who received obinutuzumab-based treatment were progression-free compared to 73.3% of patients who received rituximab-based treatment. Adverse events with either obinutuzumab or rituximab were consistent with those seen in previous studies.