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NICE backs BMS' Opdivo for melanoma

Recommendation comes despite the Institute rejecting the drug for lung cancer

NICENICE has given its blessing to the use of Bristol-Myers Squibb's Opdivo for advanced melanoma on the NHS, despite its recent rejection of the drug for lung cancer.

Final draft guidance from the UK's cost-effectiveness watchdog recommends PD-1 inhibitor Opdivo (nivolumab) for melanoma at its current price of around £5,300 (around $7,540) per month - even though the agency deemed that too high in non-small cell lung cancer (NSCLC) guidance issued last December.

"We welcome [the] decision from NICE, which is positive news for melanoma patients in the UK," said Johanna Mercier, general manager of BMS in the UK and Ireland. "However, we are mindful that lung cancer patients continue to await a final decision on this medicine."

A final verdict on the NSCLC indication is expected in May, according to BMS, which said it did not offer a discount for Opdivo in order to secure NICE backing for melanoma.

Carole Longson - NICE's Health Technology Evaluation Centre director - said the decision would be "welcome news" for the 13,000 or so people diagnosed each year with melanoma in the UK and their doctors.

In trials, Opdivo was shown to double two-year survival in some patients compared to other melanoma therapies, a finding which led to it becoming the first medicine to be cleared for the UK's Early Access to Medicines Scheme (EAMS) last year.

Institute of Cancer Research (ICR) chief executive Paul Workman welcomed the positive verdict on Opdivo, saying that because of drug resistance patients with melanoma generally have few treatment options. "So it's positive that NICE has approved this at the first time of asking."

Wider use in US
Meanwhile, patients with melanoma in the US can now be treated with Opdivo and BMS' Yervoy (ipilimumab) - regardless of their BRAF mutation status - following a new FDA approval.

The green light means that the cancer immunotherapy combination can be used in melanoma patients with BRAF V600 mutations, whereas previously it was only licensed for use in V600 wild-type tumours.

The FDA also backed use of Opdivo as single-agent to include previously-untreated BRAF-positive advanced melanoma patients. The new indications take the tally of Opdivo approvals to seven - including four in melanoma.

Article by
Phil Taylor

25th January 2016

From: Regulatory



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