Earlier this month, the National Institute for Health and Care Excellence ( NICE) published draft guidance on OPDIVO®(nivolumab) for the treatment of Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL).
The initial evidence presented by Bristol-Myers Squibb ( BMS) was immature data and did not reflect how nivolumab would be used in UK clinical practice, causing uncertainty. Thus, NICE is of the opinion to not recommend nivolumab as an option for R/R cHL after ASCT and treatment with brentuximab vedotin; unless BMS can deliver revised data.
NICE stressed that the updated analyses should include cost-effectiveness data and comparisons to the current standard of care used in the UK, using UK data.
OPDIVO® was awarded a CHMP positive opinionand approval by the European Medicines Agency ( EMA) for the treatment of R/R cHL after ASCT and treatment with brentuximab vedotin in November 2016.