FDA Approves Subcutaneous Formulation of Bristol Myers’ Opdivo for Solid Tumor Indications
Approval Date:
The FDA approved the subcutaneous formulation of Opdivo, known as Opdivo Qvantig, on December 27, 202424.
Indications:
Opdivo Qvantig is approved for all previously approved adult solid tumor indications as a monotherapy or in combination with chemotherapy or cabozantinib24.
Formulation:
The subcutaneous formulation combines nivolumab with hyaluronidase, an endoglycosidase that increases the permeability of subcutaneous tissue, allowing for faster delivery4.
Clinical Trial:
The approval was supported by data from the CheckMate-67T study, which demonstrated noninferiority of the subcutaneous formulation compared to the intravenous formulation in terms of serum concentration and objective response rate4.
Administration:
Opdivo Qvantig is administered over 3 to 5 minutes into the subcutaneous tissue of the abdomen or thigh by a healthcare provider4.
Significance:
This approval marks the first and only approved subcutaneously administered PD-1 inhibitor, enhancing patient convenience and potentially protecting sales as the intravenous formulation approaches patent expiration in 202824.
Sources:
2. https://www.targetedonc.com/view/fda-approves-subcutaneous-nivolumab-across-existing-solid-tumor-indications
4. https://www.empr.com/news/fda-approves-opdivo-qvantig-a-subcutaneous-formulation-of-nivolumab/