Regulators in the USA have given the green light to Roche’s Gazyva for chronic lymphocytic leukaemia.
Specifically, the US Food and Drug Administration has approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated CLL. The thumbs-up is based on a study of 356 participants comparing the combo to chlorambucil alone and the former demonstrated a significant improvement in progression free survival – an average of 23 months versus 11.1 months.
The approval comes with a boxed warning regarding hepatitis b virus reactivation and a rare brain disorder (progressive multifocal leukoencephalopathy). These are known risks with other monoclonal antibodies in this class and rare cases were identified in participants on other trials of Gazyva.
Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. It received the latter in May and was granted a priority review in July. The approval comes well before the date a decision was expected – December 20 – and Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said that it “reflects the promise of the BTD programme, allowing us to work collaboratively with companies to expedite the development, review and availability of important new drugs”.
At the American Society of Clinical Oncology meeting in Chicago in July, the Swiss major presented Phase III data which showed Gazyva delayed disease progression in CLL patients with CLL longer than MabThera/Rituxan (rituximab), the blockbuster Roche sells with Biogen Idec (the latter also has US rights to Gazyva). Final results from that study will be presented at the American Society of Hematology meeting in December.
Gazyva is the fifth cancer medicine from Roche approved by the FDA in the past three years. Chief medical officer Hal Barron said “we have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers”.
