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Roche's Gazyvaro cleared for follicular lymphoma in Europe

Second indication anticipated to increase peak sales by up to $1bn

Roche has been granted EU approval for a second indication its Gazyvaro product adding follicular lymphoma to current use in chronic lymphocytic leukaemia.

The anti-CD20 antibody, a follow-up to Roche's big-selling MabThera/Rituxan (rituximab) product, has been approved in combination with bendamustine - followed by maintenance therapy with Gazyvaro (obinutuzumab) alone - for follicular lymphoma previously receiving MabThera-based therapy.

The product has been on the market for CLL since 2013 but has yet to gain much sales momentum, bringing in sales of around $128m last year as it jostled for market share with other new CLL drugs such as Johnson & Johnson's Imbruvica (ibrutinib) and Gilead Sciences' Zydelig (idelalisib).

Follicular lymphoma is a much larger market - the disease is a subset of non-Hodgkin's lymphoma and accounts for around 20% of all NHL cases - and according to some analysts could kick-start the growth of the product. Around 50 people in Europe are diagnosed with the disease every day, according to Roche.

Analysts have suggested that use of the drug in the MabThera-refractory follicular lymphoma population could add $500m to $1bn to Gazyvaro's peak sales.

The approval in Europe follows a green light for follicular lymphoma in the US earlier this year, where the drug is known as Gazyva. It is based on the results of the GADOLIN trial, which showed Gazyvaro plus bendamustine more than doubled median progression-free survival (PFS) to 29 months, compared to less than 14 months for bendamustine alone.

Roche's chief medical officer Sandra Horning said the approval was a "significant milestone" for European patients with follicular lymphoma who "fail to achieve durable disease control with MabThera-based treatment".

MabThera has remarkable efficacy in this form of cancer with initial response rates touching 90%, but patients inevitably relapse and the disease gets increasingly hard to treat each time it returns.

Gazyvaro will still have to contend with competition in the follicular lymphoma market. Zydelig is already approved for use in combination with MabThera and in MabThera-refractory. Prospects for Zydelig have however been clouded somewhat by recent reports of serious adverse events in clinical trials.

Imbruvica is also in late-stage testing in follicular lymphoma, although preliminary results have been a little disappointing in terms of response rates. It has been suggested the drug may prove more valuable in combination with other drugs such as checkpoint inhibitors in this form of cancer.

Article by
Phil Taylor

16th June 2016

From: Regulatory



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