- Opdivo® with ENHANZE® technology receives European Commission approval for subcutaneous use.
- The new formulation facilitates a quick 3-to-5-minute injection, enhancing patient convenience.
- Approval covers multiple solid tumor indications across all 27 EU member states, plus Iceland, Liechtenstein, and Norway.
Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission has approved a new subcutaneous formulation of Opdivo® (nivolumab), developed using Halozyme's proprietary ENHANZE® technology. This significant approval marks Opdivo® as the first and only PD-1 inhibitor approved for subcutaneous administration in the European Union.
The new subcutaneous administration method allows cancer patients to receive their treatment through a convenient 3-to-5-minute injection, a notable improvement over traditional intravenous methods. The approval, based on the successful results from the Phase 3 CheckMate -67T trial, applies to a broad range of adult solid tumor indications.
This regulatory approval is valid across all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway, expanding the availability of this innovative treatment method across Europe. This approval follows the U.S. FDA's prior approval of Opdivo Qvantig™ on December 27, 2024, further enhancing the global reach of Halozyme's cutting-edge ENHANZE® technology.
