NICE u-turn on Opdivo for skin cancer recurrence

NHS use of Bristol-Myers Squibb’s Opdivo to cut the risk of early stage skin cancer recurrence after surgery has now been approved by the National Institute for Health and Care Excellence

The Institute rejected use of the drug in this setting earlier this year on grounds that it was not cost-effective enough, but has now released draft guidelines endorsing its use, with funding via the Cancer Drugs Fund.

According to the firm, the approval marks a change in the treatment of melanoma for patients eligible for surgery, who are currently only monitored to see if their cancer returns, which is known as the "watch and wait" approach.

"There have been huge advances in the treatment of advanced melanoma in recent years, but cure rates are low. So, being able to give nivolumab to high risk patients after their surgery is a significant step forward in improving outcomes for what can be a devastating disease," said Dr Pippa Corrie, consultant and Associate Lecturer in Medical Oncology, Cambridge University Hospitals NHS Foundation Trust.

The incidence of melanoma in the UK has has more than doubled in the last 25 years or so.

Typically, around 68% of patients with stage IIIb, and 89% of those with stage IIIc, melanoma may experience a recurrence of their cancer within five years of surgery, BMS said, highlighting the unmet need in the area.

In the Phase III Checkmate 238 trial, at 24 months 63% of patients treated with Opdivo (nivolumab) did not experience a recurrence of their cancer, compared to 50% given Yervoy (ipilimumab).

Veronique Walsh, general manager, Bristol-Myers Squibb UK & Ireland, said NICE’s recommendation "represents an important step forward in improving outcomes for melanoma patients by treating them with immunotherapy earlier as the first IO treatment available in the UK".

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