Certain patients with breast cancer may soon be able to get routine access to Eisai's Halaven on the NHS in England and Wales, after cost regulators endorsed its use.
The drug was deemed too costly for NHS use back in 2012 because of uncertainties in effectiveness data.
However, new evidence has led to draft updated guidance from the National Institute for Health and Care Excellence in which Halaven (eribulin) is being recommended as an option for people with locally advanced or metastatic breast cancer that has spread after at least two chemotherapy regimens.
"For this appraisal we've been able to consider updated results from the trial used in the original guidance that show women taking eribulin lived on average almost 3 months longer compared with women taking other treatments," noted Professor Carole Longson MBE, director of the centre for health technology evaluation at NICE.
"We've also been able to take into account the results for health-related quality-of-life from another trial that compared eribulin with capecitabine. This new evidence, together with the discount available through the patient access scheme, enabled the appraisal committee to conclude that erubilin represents good value for money."
In light of the short life expectancy of people with this stage of breast cancer - typically less than two years - the committee felt that the overall survival benefit shown in the EMBRACE trial compared to standard treatment was "substantial", and that the drug therefore met NICE's end-of-life criteria.
Taking together all the uncertainties, the committee considered the most plausible incremental cost effectiveness ratio to be below £50,000 per QALY gained.
Halaven, which belongs to a class of antineoplastic agents, the halichondrins, that are derived from the marine sponge Halichondria okadai, was first approved for breast cancer in the US in 2010 and in the EU in 2011, and also won FDA clearance for liposarcoma back in January.
The Scottish Medicines Consortium backed use of Halaven for the treatment of advanced breast cancer in March.