Bristol Myers Squibb (BMS) has announced that an injectable version of its cancer immunotherapy Opdivo (nivolumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for multiple solid tumour indications.
Subcutaneous (SC) Opdivo, which is co-formulated with recombinant human hyaluronidase, can be given as a three-to-five minute injection, compared to a 30-to-60 minute infusion for the drug’s intravenous (IV) form.
It is hoped that this will enable patients to spend less time in hospital, as well as free up staff capacity to deliver more appointments and treatments.
The new formulation has been indicated for fortnightly or monthly use across 15 cancer types, including certain cases of lung, bowel, liver, kidney, bladder, oesophageal, skin, and head and neck cancers.
Opdivo is a programmed death-1 immune checkpoint inhibitor that is designed to use the body’s own immune system to help restore anti-tumour immune response.
It is estimated that around 1,200 patients in England per month could benefit from the newly approved formulation, according to NHS England.
The MHRA’s decision was based on results from the phase 3 CheckMate-67T trial, in which SC Opdivo produced comparable levels of drug in the body and a similar safety and tumour response profile to the IV formulation in adults with advanced or metastatic clear cell RCC who had received prior systemic therapy.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “This approval marks an important step forward in improving treatment access and reducing the time patients spend in clinics. It has the potential to ease pressures on NHS services, while also giving patients flexibility in their care.”
Sharing a similar sentiment, Rob Duncombe, chief pharmacist at the Royal Marsden NHS Foundation Trust, said: “The approval of SC [Opdivo] offers eligible patients a new way to receive this drug that may provide greater flexibility while delivering the same efficacy as achieved with IV [Opdivo].”
“SC [Opdivo] may reduce chair time for patients and increase the options as to where they can receive their treatment, allowing for an overall more convenient treatment experience,” he added.