BMS files Opdivo for new use in US and Europe
Regulators in the US and EU are considering a new use for Bristol-Myers Squibb’s Opdivo cancer immunotherapy in head and neck cancer.
Both the US Food and Drug Administration and the European Medicines Agency have accepted filings for Opdivo (nivolumab), for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck.
The FDA has granted a faster, six month review and is due to make a decision on the new use in November.
Opdivo was first approved in melanoma but BMS is developing it in a range of other uses, and sales could peak as high as $13 billion, according an analysis by Jeffries last year.
The drug is already approved in the US in lung cancer, in combination with BMS’s Yervoy in certain skin cancers, in advanced lung cancer and renal cell carcinoma.
A PD-1 inhibitor, the drug works by instructing the body’s own T-cells to attack tumours. It faces competition from Merck's Keytruda (pembrolizumab), which is in the same class.
Both US and European filings were based on the phase 3 CheckMate – 141 trial, which evaluated overall survival in head and neck cancer patients after platinum therapy treated with Opdivo, compared with investigators’ choice (methotrexate, docetaxel, or cetuximab).
The trial was stopped early by an independent data monitoring committee because it met its endpoint.
But when the drug might reach patients in the UK with this cancer is a different matter.
NICE has rejected Opdivo in lung cancer in first draft guidance, meaning England’s NHS will not regularly fund it unless the manufacturer drops its price or presents new cost-effectiveness data.
But the Scottish Medicines Consortium has recommended funding, so lung cancer patients north of the border will receive it routinely on the NHS.
NICE has also rejected Opdivo in kidney cancer in first draft guidance published earlier this month.
However England’s cancer drug funding system is in a state of flux, with new arrangements for the Cancer Drugs Fund beginning this week, which will see pharma companies pay a rebate if it exceeds spending limits.
NICE will also change its approach to assessing drugs, potentially with less rigid data requirements.
So the new indication for Opdivo could become a test case for the new system if it is approved in Europe.