FDA Approves Roche’s New Leukemia Drug

Roche is celebrating after its blood cancer drug Gazyva was approved in the US to treat people with previously untreated chronic lymphocytic leukemia (CLL).

The medicine is the first with the FDA’s ‘breakthrough therapy’ designation to be approved and will help Roche stem the inevitable loss in revenue from its $7 billion a year CLL brand MabThera (rituximab) – sold as Rituxan in the US – which will shortly face generic competition.

In fact Roche released data earlier this year this year which showed that Gazyva was a better treatment than Rituxan for CLL. Gazyva (obinutuzumab) is to be used with chlorambucil chemotherapy after the combination demonstrated an 84% reduction in the risk of the disease worsening, or death, compared to chemotherapy alone.

The FDA gave Gazyva priority review and orphan product designation: CLL is the most common form of leukemia in adults, with 11,000 new cases in Europe and 15,600 in the US each year.

“Gazyva is an important new medicine for people with newly-diagnosed CLL as based on clinical data it more than doubled the time people lived without their disease worsening,” said Hal Barron, Roche’s chief medical officer.

Marketing applications have been submitted to other regulatory authorities, including the EMA, and the Swiss manufacturer says it will also look at Gazyva’s effectiveness in other types of blood cancers. Marketed rivals in CLL include Napp’s Levact (bendamustine), while GlaxoSmithKline and Genmab recently submitted their CLL candidate Arzerra to both European and US regulators for first-line approval.

This drug is being considered, in combination with an alkylator-based therapy, for CLL patients who have not been treated before and who cannot have fludarabine-based therapy.

Arzerra was first approved in 2009 as a second-line treatment for CLL, but as this is a small market it only managed to make $100 million in revenue last year – but the new licence it is seeking could tip it into blockbuster status. Gazyva works by helping certain cells in the immune system attack cancer cells and FDA approval was based on the CLL11 trial, which showed that people in the Gazyva arm had median progression-free survival of 23 months versus 11.1 months for those on chemotherapy alone.

Final data from CLL11 – revealing a direct comparison between Gazyva with chlorambucil and Rituxan with chlorambucil – will be presented at the American Society of Hematology’s annual meeting next month.


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