Bristol-Myers Squibb (BMS) could see an early launch of its new melanoma therapy Opdivo in the UK after becoming the first drug of its class given a new fast-track status by the country’s drugs regulator.
The Medicines and Healthcare products Regulatory Agency (MHRA) has labelled PD-1 inhibitor Opdivo (nivolumab) a Promising Innovative Medicine (PIM), the first stage in the UK’s Early Access to Medicines Scheme (EAMS) which was launched in April 2014.
PIM is an early signal to companies that their development plans for a new therapy are on the right track for the EASM, which aims to increase patient access to medicines where there is an unmet medical need.
Until now, the only PIM granted under the scheme was for Northwest Biotherapeutics’ cell-based therapy DCVax-L for a form of brain cancer known as malignant glioma.
The award of PIM status is followed by a review of the benefit and risks of the medicine by the MHRA, which then delivers a scientific opinion based on the data available at the time of the EAMS submission. In that respect it is similar to the ‘breakthrough’ designation recently introduced by the US FDA.
According to the regulator, the opinion “will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.”
The PIM award for Opdivo comes on the back of robust efficacy data for the immuno-oncology therapy in melanoma, an indication for which it has already been approved in Japan and the US.
When the EASM was launched it was feted by Health Secretary Jeremy Hunt as a major boost for the UK life sciences industry, although companies were a little more guarded in their response.
Whilst backing the approach in principle, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) had qualms about the funding of the scheme, in particular that companies will foot the bill for making the drugs available under the EASM.
Drugs made available under the new process will be effectively free for NHS patients, but it has been suggested that some companies – and particularly smaller enterprises making drugs that are expensive to manufacture – will be unable to afford to take part.
“We are … delighted that nivolumab has become one of the first medicines to be awarded a PIM designation,” commented Johanna Mercier, general manager of BMS UK & Ireland.
“We will now work closely with the NHS to ensure all those eligible are able to benefit from this breakthrough treatment as soon as possible,” she promised.