Subcutaneous Opdivo Receives FDA Approval for Advanced, Metastatic Solid Tumors

Key Takeaways

Opdivo Qvantig is approved for solid tumors, including melanoma, renal cell carcinoma, and non-small cell lung cancer.
The CHECKMATE-67T trial showed a 24% response rate for subcutaneous Opdivo Qvantig versus 18% for intravenous Opdivo.
Safety profiles for subcutaneous and intravenous Opdivo were similar, with common side effects like musculoskeletal pain and fatigue.
Dosage of Opdivo Qvantig varies by indication and is based on disease progression and toxicity.

Opdivo Qvantig received FDA approval for all previously approved indications in solid tumors.

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The FDA approved a subcutaneous formulation of Opdivo for previously approved solid tumor indications.

The Food and Drug Administration (FDA) approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), a subcutaneous injection formulation of Opdivo, for previously approved solid tumor indications of Opdivo.

According to a notice from the FDA, these indications are including as monotherapy, monotherapy maintenance after completing Opdivo and Yervoy (ipilimumab) or in combination with cabozantinib or chemotherapy. In addition, particular disease states include melanoma, renal cell carcinoma, head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, urothelial carcinoma, esophageal carcinoma, hepatocellular carcinoma, gastroesophageal junction cancer, gastric cancer and esophageal adenocarcinoma.

The FDA noted that Opdivo Qvantig is not indicated in combination with Yervoy that is administered intravenously.

The FDA approval of Opdivo Qvantig was based on findings from the CHECKMATE-67T trial, which included patients with advanced or metastatic clear-cell renal cell carcinoma treated with no more than two prior systemic treatment regimens, according to the notice. In the trial, 495 patients were randomly assigned to receive either subcutaneous Opdivo Qvantig or intravenous Opdivo.

The main area of focus in the CHECKMATE-67T trial was the exposure to Opdivo via subcutaneous administration compared to intravenous Opdivo. Another area of interest was overall response rate, which was 24% in the subcutaneous group compared with 18% in the intravenous group.

Glossary

Subcutaneous: beneath the skin

Overall response rate: how many patients experienced a significant shrinkage or disappearance of their tumors after treatment

The notice mentioned that the safety findings from the CHECKMATE-67T trial were similar between subcutaneous Opdivo Qvantig and intravenous Opdivo. The most common side effects, occurring in at least 10% of patients, included musculoskeletal pain, fatigue, rash, itching and cough.

According to the FDA, the recommended dosage of Opdivo Qvantig depends on the specific indication it is being used for. The agency noted several doses to be given until disease progression, unacceptable toxicity or as indicated in the prescribing information.

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