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Just after Christmas, the US Food and Drug Administration (FDA) granted approval for an injectable form of nivolumab for the treatment of most previously approved 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.
“This approval of subcutaneous nivolumab gives our patients a new option that can deliver consistent efficacy and comparable safety expected from IV nivolumab, and offers a patient-centric treatment experience,” said Professor Saby George, medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center in New York. “[Subcutaneous nivolumab] offers faster administration, delivered in three to five minutes. It may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home.”
Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their healthcare team, and may reduce the steps needed for preparation and time for administration. With this approval, nivolumab is now the first and only subcutaneously administered immunotherapy, offering faster delivery for patients to receive this treatment option in three to five minutes compared to a 30-minute intravenous infusion of nivolumab.
This new form of nivolumab is yet to be approved for use in the UK by the regulators.
