UK blood cancer patients get early access to BMS drug

UK blood cancer patients will be able to get access to Bristol-Myers Squibb’s (BMS) cancer immunotherapy, nivolumab, after the regulator granted early access ahead of its European licence.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted access to the medicine, which is not yet approved as monotherapy for adults with relapsed classical Hodgkin lymphoma (cHL) after autologous stem cell transplact (ASCT) and treatment with Takeda's Adcetris (brentuximab vedotin).

Funded by BMS, nivolumab, marketed in other indications as Opdivo, has been made available in the blood cancer indication under the Early Access to Medicines Scheme (EAMS), after it was granted Promising Innovative Medicine (PIM) status for the fifth time.

The decision was made on the strength of pivotal phase 2 data published in The Lancet Oncology, showing the number of patients treated with nivolumab with considerable tumour reduction was 66.3%.

Nivolumab is a PD-1 immune checkpoint inhibitor that works by harnessing the ability of the immune system to fight some types of cancer, including classical Hodgkin lymphoma, advanced lung, skin, and kidney cancer. It is being investigated in several other cancer types.

In England and Wales, since licensing and NICE review, only those patients with advanced (metastatic or unresectable) skin cancer and advanced kidney cancer (after prior therapy) are currently able to receive treatment with nivolumab.

Access to nivolumab for NHS patients in England and Wales who have advanced lung cancer remains uncertain, with draft NICE guidance published recommending restrictions that could deny treatment for up to two thirds of patients.

In October, NICE said in final draft guidance that BMS must make the case for nivolumab to be included on England’s Cancer Drugs Fund, and only for patients with higher levels of the PD-L1 receptor on their tumours.

Benjamin Hickey, general manager of UK and Ireland for BMS, said the company was continuing to work with NICE and NHS England to make nivolumab available in lung cancer.

Last year, MSD’s rival anti-PD1 therapy, Keytruda (pembrolizumab), became the first drug accepted on EAMS, for use in advanced melanoma.