UK backs early access to BMS’s Opdivo for lung cancer

Patients with lung cancer in the UK can now get treatment with Bristol-Myers Squibb's Opdivo under a new scheme designed to accelerate access to new drugs.

Opdivo (nivolumab) has been included in the UK's Early Access to Medicines Scheme (EAMS) for patients with advanced metastatic or unresectable squamous non-small cell lung cancer (NSCLC).

The drug became the first PD-1 checkpoint inhibitor to be approved in the EU last month - pipping rival Keytruda (pembrolizumab) to the post – after it was given a green light from the European Medicines Agency as a therapy for the skin cancer melanoma.

Opdivo is approved to treat NSCLC in the US but not yet in the EU, so the approval by the Medicines and Healthcare products Regulatory Agency (MHRA) is good news for UK patients waiting for access to the drug. Formal EU approval of the drug in NSCLC is likely not far off, however, as it was backed by the EMA's Committee for Medicinal products for Human Use last month.

The EAMS was introduced last year to make it possible for patients with serious diseases to get access to new therapies before a European licence has been granted and ahead of cost-effectiveness appraisal by the National Institute of Health and Care Excellence (NICE), but after the MHRA has conducted a benefit/risk assessment.

Once formal EU approval comes through – most likely by September – the EAMS is closed to new patients although those already receiving the drug can continue on therapy.

The MHRA approval is based on data from the pivotal CheckMate-017 study, which showed that Opdivo achieved a one-year overall survival rate of 42 percent in NSCLC patients compared to 24 percent for docetaxel, the current standard treatment. Median overall survival was extended by more than half to 9.2 months.

Keytruda became the first drug to be approved by the MHRA under the EAMS in March, when it was cleared for use in melanoma patients, with Opdivo getting the nod in the same indication a couple of months later.

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 EAMS, giving them the best possible chance to fight their condition," he added.