The UK’s drug regulator has approved Bristol-Myers Squibb’s new lung cancer drug Opdivo for use in the country under a new scheme design to speed up market access in the country.
The MHRA formally adopted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the firm’s investigational PD-1 (programmed death-1) immune checkpoint inhibitor, Opdivo (nivolumab).
It has been approved as a treatment option for patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy.
The drug was also granted a licence to treat late-stage melanoma in Europe just last week. In May, the drug received a positive opinion from the European Medicines Agency in NSCLC as a second line therapy, but has not yet been given final approval, which is expected by September.
This latest EAMS decision will therefore allow UK patients access Opdivo ahead of its marketing authorisation in lung cancer from the European Commission.
Once the drug has been licensed by the European Commission, however, the EAMS closes to new participants, although those already enrolled will continue to be provided with the treatment, according to NHS England.
A number of treatments have already been accepted under this system for other cancers, including for Opdivo’s melanoma licence, as well as for Merck & Co’s rival drug PD-1 drug Keytruda (pembrolizumab), also in melanoma.
Commenting on the latest decision life sciences minister George Freeman said: “Lung cancer is a devastating disease and the positive scientific opinion of nivolumab offers real hope to those who need it most.
“The government is committed to accelerating access to new 21st century medicines and I hope this is just one of many drugs that will be made available to patients through the Early Access to Medicines Scheme, giving them the best possible chance to fight their condition.”
Johanna Mercier, general manager at Bristol- Myers Squibb UK & Ireland, added: “[Opdivo] is the first treatment for lung cancer to be made available through the EAMS and we are committed to continued collaboration with policy makers to ensure that UK patients can benefit from our innovative cancer medicines.”
NICE, and the cost of lung cancer
Lung cancer is the second most common cancer in the UK with over 43,000 cases reported in 2011.
Whilst lung cancer includes many different forms of the disease, NSCLC is the most common type, accounting for around 87% of cases.
There are already a number of treatments available in the UK for various forms and mutations associated with NSCLC, including AstraZeneca’s EGFR drug Iressa (gefitinib), as well as Lilly’s Alimta (pemetrexed), and Roche’s Tarceva (erlotinib) – all of which have seen positive NICE recommendations.
However some new NSCLC have not been made regularly available as NICE has deemed them too expensive for the NHS – this includes Roche’s Avastin (bevacizumab) and Pfizer’s ALK drug Xalkori (crizotinib).
Under the EAMS project, NICE is essentially by-passed as most of the funding for these medicines will come from the industry, rather than from the NHS. NICE will look at the cost-effectiveness of a drug approved under EAMS after a positive recommendation.