Bristol-Myers Squibb has launched its PD-1 inhibitor Opdivo (nivolumab) in the UK as a second-line therapy for squamous non-small cell lung cancer (NSCLC) after chemotherapy.
The new drug – launched as Nivolumab BMS in the UK – is the first of the new checkpoint inhibitor class of cancer immunotherapies to reach the UK market for NSCLC, which is diagnosed in more than 40,000 people every year and kills more people than breast and bowel cancer.
Nivolumab first reached the market in the UK at the end of June under the Opdivo brand name for the skin cancer melanoma, just ahead of rival PD-1 inhibitor Keytruda (pembrolizumab) from Merck & Co, which according to the UKMi database launched for melanoma in mid-July.
Both drugs were approved under the UK’s Early Access to Medicines Scheme (EAMS) ahead of a formal green light from the European Medicines Agency (EMA).
Commenting on the launch for lung cancer, Dr Sanjay Popat of the Royal Marsden hospital said: “This group of patients with relapsed squamous-type lung cancer represents a considerable unmet medical need in the UK, as chemotherapy has been their main option until now.”
Many patients at advanced stages of this disease are unable to tolerate the side effects of chemotherapy and some patients will choose to discontinue treatment, he continued.
“The launch of nivolumab is a milestone that changes the treatment landscape from one where existing treatment options have offered modest improvements in survival, to one where lung cancer patients have an additional option which can significantly extend survival,” said Popat.
A spokesperson for BMS said the monthly cost of treatment for nivolumab in NSCLC is approximately £5,700 ($8,800) for the average patient – based on treatment with the licensed dose of 3mg/kg every 2 weeks – which is roughly in line with its monthly cost as a melanoma treatment.
In the US, the average cost per patient is around $12,500/month for squamous NSCLC based on the same dosing, she added.
The high price of new cancer drugs has sparked considerable debate about the sustainability of the model for funding healthcare, so nivolumab’s appraisal by UK health technology assessment (HTA) agency NICE will be viewed with intense interest, particularly as it has strong clinical data backing its efficacy.
The first scheduled review meeting for nivolumab by NICE will take place on 18 November, and final guidance is not expected until May 2016, according to BMS.
“The next step will be to ensure that eligible patients in the UK are able to benefit from nivolumab as soon as possible and we are totally committed to continued collaboration with the reimbursement authorities to achieve this,” commented Johanna Mercier, general manager for BMS UK & Ireland.