FDA Approves Injectable Nivolumab, an Alternative to IV Infusion
, by Nadia Jaber
Because Opdivo Qvantig is given as an injection, it should be much more convenient for patients than the original formulation of Opdivo (nivolumab), which had to be given as an infusion, several oncologists said.
A form of nivolumab that can be injected under the skin (subcutaneous) has gained approval from the Food and Drug Administration (FDA). The approval allows the injectable version to be used for most of the same patient groups as the original formulation, which is given as an infusion through a vein (intravenous or IV).
Experts say the injectable version of nivolumab, also called Opdivo Qvantig, will make the treatment quicker and easier for patients to get. The injection takes less than 5 minutes, compared with about 30 minutes for the infusion.
The injection, which is usually given in the abdomen or thigh, doesn’t require a surgically implanted port, which is sometimes needed for intravenous nivolumab. And the new formulation may eventually allow patients to get the treatment at their oncologists’ office, or even at home.
The injectable form of nivolumab allows for greater convenience for patients while maintaining the treatment’s efficacy, said James Gulley, M.D., Ph.D., co-director of NCI’s Center for Immuno-Oncology.
This is not the first approval of an injectable form of an immune checkpoint inhibitor. A subcutaneous version of atezolizumab (Tecentriq) was approved in September. Pharmaceutical companies are also developing subcutaneous versions of other immunotherapy drugs, including pembrolizumab (Keytruda) and blinatumomab (Blincyto).
The approval of subcutaneous nivolumab is based on results from a clinical trial comparing both forms of nivolumab in people with advanced kidney cancer. The trial showed that both forms of the drug had similar pharmacokinetics, meaning how the drug is absorbed, broken down, and excreted in the body. And subcutaneous nivolumab was as safe and effective, in terms of objective response rates, as intravenous nivolumab.
The clinical trial results that formed the basis for the new approval are covered in more detail in this March 2024 Cancer Currents story.