Bristol-Myers Squibb’s nivolumab has become the first PD-1 compound to receive Promising Innovative Medicine status from the Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of advanced skin cancer.
The designation basically means the drug could be eligible for the UK’s Early Access to Medicines Scheme, designed to offer patients with life-threatening or seriously debilitating conditions the chance to receive innovative new drugs potentially years ahead of when they normally would, before approval from the European Commission.
Importantly, the PIM also serves as an early signal to companies that a development plan is on the right track, indicating that a product could be a candidate for the EAMS when further necessary work has been conducted.
More than 13,000 people a year are diagnosed with melanoma in the UK. Phase III trials of Nivolumab have shown impressive response rates in patients (32% versus 11% for doctor’s choice of care), as well as a favourable duration of response and safety profiles.
Nivolumab is the third drug to pick up PIM status in the UK since the scheme’s introduction last year, and B-MS says it “will now work closely with the NHS to ensure all those eligible are able to benefit from this breakthrough treatment as soon as possible”.
Nivolumab, which was approved in the US for advanced melanoma in December under the trade name Opdivo, is a central vein of B-MS’ immuno-oncology portfolio, which is focused on harnessing the power of the body’s own immune system to fight cancer.