Three to five minutes. That is how long a nurse needs to give the new subcutaneous form of Opdivo, according to Bristol Myers Squibb, against 30 minutes for the intravenous drug. The US Food and Drug Administration cleared the injection on December 27, 2024, under the name Opdivo Qvantig.
Nothing about the cancer drug itself is new. The active ingredient is still nivolumab, a PD-1 inhibitor already in clinics for years. What changed is the way it reaches the body. Nivolumab is now co-formulated with hyaluronidase-nvhy, using Halozyme’s ENHANZE delivery technology, so it can go under the skin instead of through an IV line. The company describes it as the first and only PD-1 inhibitor given this way.
Where it can be used
The approval is broad but not complete. Opdivo Qvantig is cleared for most adult solid-tumour uses of intravenous Opdivo: as a single agent, as maintenance after a course of nivolumab plus ipilimumab (Yervoy), or alongside chemotherapy or cabozantinib (Cabometyx). The cancers named run from kidney and melanoma through non-small cell lung, then head and neck squamous cell, urothelial, colorectal and liver, to oesophageal, gastric and gastroesophageal junction tumours.
One combination is excluded. The label does not cover use together with intravenous ipilimumab.
What the trial showed
Regulators leaned on CheckMate-67T, a phase 3, open-label, randomised trial in previously treated adults whose kidney cancer, of the clear cell type, was advanced or had spread. It was designed to show the injection was not inferior to the infusion, and the measure was drug levels in the blood rather than survival. In the subcutaneous arm (242 patients) the 28-day geometric mean averaged 77.373 μg/ml, against 36.875 μg/ml in the intravenous arm (245 patients). The trough level at steady state came to 122.227 μg/ml versus 68.901 μg/ml.
Both prespecified endpoints met the non-inferiority bar. The overall response rate was 24% with the injection and 18% with the infusion. OncLive read that gap as a possible sign of enhanced efficacy. Disease control, time to response, progression-free survival and overall survival were numerically similar between the arms, and the safety profiles looked alike. In the injection arm, fatigue, musculoskeletal pain, itching, rash and cough were each reported by at least 10% of patients.
Dosing
The schedule depends on the cancer. The label lists 600 mg of nivolumab with 10,000 units of hyaluronidase every 2 weeks, 900 mg with 15,000 units every 3 weeks, or 1200 mg with 20,000 units every 4 weeks. Treatment continues until the disease progresses or toxicity becomes unacceptable.
Bristol Myers Squibb argues that the shorter administration may give patients and providers more freedom to choose where treatment happens, and may cut the preparation steps. The pivotal data, though, concern drug exposure in kidney cancer.
Sources
- FDA Approves Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors | OncLive
- FDA Approves BMS’ Opdivo Qvantig with Halozyme's ENHANZE Technology | Contract Pharma
