The National Institute for Health and Clinical Excellence (NICE) today issued draft guidance on Halaven® (eribulin) for public consultation. The draft guidance does not recommend NHS funding of eribulin, a treatment for locally advanced or metastatic breast cancer.

Eribulin is a novel treatment indicated for patients with locally advanced or metastatic breast cancer whose disease has progressed after at least two chemotherapeutic regimens for advanced and metastatic disease.

It was launched in the UK in April 2011 and some patients have already started to benefit from treatment. Before the approval of eribulin in the EU, no single treatment has demonstrated a statistically significant prolongation of median overall survival as shown in the clinical trial.

"We are hugely disappointed with the draft guidance issued by NICE. It has not recommended an innovative treatment for a vulnerable group of women with heavily pre-treated locally advanced or metastatic breast cancer, with a proven overall survival benefit," commented Nick Burgin, European Director of Market Access, Eisai.

He adds; "Despite the UK price of eribulin currently being the lowest in the world, and a further patient access scheme agreement with the Department of Health which makes eribulin available at a discounted price, and unique real-world comparative data that has demonstrated overall survival, NICE's unwillingness to approve this treatment is a real surprise."

There is a clear unmet need for treatments that improve overall survival for women with locally advanced or metastatic breast cancer, particularly those who do not respond or become refractory to treatments such as anthracyclines and taxanes and, in many cases, capecitabine.

Eribulin is approved in the European Union, USA, Switzerland, Japan, and Singapore. Eribulin is currently commercially available in Austria, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Singapore, Switzerland, United Kingdom, and the USA and will become commercially available in Japan on 19 July 2011.

The draft guidance is based on the Phase III data showing a median overall survival benefit of 13.1 months for patients receiving eribulin compared to 10.6 months for patients receiving 'treatment of physician's choice' (TPC).

The side-effect profile of eribulin was expected and manageable. The most commonly reported adverse reactions among patients were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.i Limited inference can be drawn from direct comparison of safety between patients treated with eribulin and those treated with TPC, as each of the therapies in the TPC group has a distinct safety profile. However, comparisons between eribulin and TPC showed that serious adverse events occurred in 25% of patients on eribulin and 26% of those on TPC, and adverse events leading to therapy discontinuation occurred in 13% of eribulin patients and 15% of TPC patients.

Professor Neville Davidson, Consultant Oncologist commented; "Having treated patients with eribulin, there were no unexpected side-effects in comparison with other treatments options in heavily pre-treated patients with locally advanced or metastatic breast cancer."

Pre-planned analysis of patients from geographical region 1 (North America/Western Europe/Australia) best represent how patients in the UK are managed and showed a significant overall survival benefit of eribulin over TPC of 3.0 months, nominal p=0.031 (updated analysis).

Eisai is currently evaluating the ACD and will be responding to the preliminary guidance to reverse the recommendations so that more patients can benefit from treatment with eribulin.




Source: Esai