Dr. Balazs Halmos discusses the significance of the FDA approval of the subcutaneous injection formulation of Opdivo for patients with solid tumors. The Food and Drug Administration (FDA) approval of ...
The U.S. Food and Drug Administration has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use for most previously approved adult, solid tumor Opdivo ...
Subcutaneous nivolumab and hyaluronidase-nvhy is FDA-approved for adult solid tumors, offering a new administration route for PD-1 inhibitors. The phase 3 CheckMate-67T trial confirmed ...
In the study, the subcutaneous formulation matched up to the IV on both co-primary pharmacokinetics endpoints as well as the key secondary endpoint of tumor ... an IV—before surgery, and then ...
The product is administered over a period of 3 to 5 minutes into the subcutaneous tissue of the ... option used in many indications across tumor types,” said Adam Lenkowsky, executive vice ...
injection for subcutaneous use for most previously approved adult, solid tumor Opdivo (nivolumab) indications. Opdivo Qvantig is a combination product of nivolumab coformulated with recombinant ...
injection for subcutaneous use. This combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20) is approved for most previously approved adult solid tumor Opdivo ...