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The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has approved an injectable form of nivolumab for the treatment of solid tumours, including advanced kidney cancer. The injectable form of nivolumab can be given alone, as maintenance therapy following completion of nivolumab plus ipilimumab combination treatment, or in combination with chemotherapy or cabozantinib.
The approval is based on the results from the phase 3 CheckMate-67T trial, which showed the injectable form of the drug allows large volumes of nivolumab, currently administered intravenously (IV) as an infusion, to be delivered as an injection under the skin (subcutaneous). The trial also showed that nivolumab given subcutaneously has similar effectiveness compared to the intravenous (IV) form of nivolumab.
This new option for giving nivolumab as a single injection administered in less than five minutes, could transform the treatment experience for both patients and doctors.
Julian Beach from the MHRA said: “Patient safety is our top priority, which is why I am pleased to confirm the national approval of the new under-the-skin injection version of nivolumab.
“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.
“We’re assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.”
Read more in the MHRA press release here
The nivolumab injection will be made available to NHS patients:
