Halozyme Therapeutics

FDA approves first injectable immune checkpoint inhibitor, Tecentriq Hybreza, reducing administration time to 7 minutes from 30-60 minutes for IV infusions. Approved for same indications as Tecentriq infusions, it uses Enhanze technology for rapid dispersion. Based on IMscin001 trial, drug levels and safety profiles were similar to IV formulation. 71% preferred injectable version for less clinic time and increased comfort.

Roche's Ocrevus Zunovo, a subcutaneous formulation combining ocrelizumab with Enhanze technology, has been approved by the FDA for treating both relapsing and primary progressive MS. Administered in about 10 minutes, it maintains the same twice-yearly dosing as the IV version, with comparable safety and efficacy. Over 92% of patients in the OCARINA II trial were satisfied with the SC administration.

Roche's Ocrevus Zunovo, combining ocrelizumab and hyaluronidase-ocsq with Halozyme's Enhanze drug delivery tech, received FDA approval for subcutaneous injection treatment of relapsing and primary progressive multiple sclerosis. The twice-yearly, ten-minute injection offers flexibility and comparable safety and efficacy to intravenous formulation, with over 92% of trial participants satisfied with the subcutaneous method.

Roche’s Tecentriq Hybreza, a subcutaneous PD-L1 inhibitor, approved by the FDA for multiple cancer types, offering a 7-minute injection compared to 30-60 min IV infusion. The SC formulation, combining Tecentriq with Halozyme’s Enhanze technology, is the first and only SC anti-PD-L1 immunotherapy in the US, applicable to all adult indications of IV Tecentriq. Phase 1b/3 study results showed comparable efficacy and safety profiles, with 71% of patients preferring Tecentriq Hybreza for its quicker administration and reduced clinic time.

Roche's Ocrevus Zunovo, combining Ocrevus with Halozyme's Enhanze drug delivery tech, receives FDA approval for subcutaneous injection in treating relapsing and primary progressive multiple sclerosis, offering a twice-yearly, ten-minute treatment option with comparable safety and efficacy to intravenous administration.

FDA approves OCREVUS ZUNOVO™, a twice-a-year subcutaneous injection for relapsing and primary progressive multiple sclerosis, offering more treatment options and flexibility.

FDA approves subcutaneous versions of Roche's biologic drugs: Tecentriq Hybreza for cancer (7-min injection, 3.8B Swiss francs revenue) and Ocrevus Zunovo for MS (10-min injection, 6.4B Swiss francs revenue), both offering faster dosing times and broader accessibility.

Halozyme Therapeutics announces FDA approval for Roche's Tecentriq Hybreza, a subcutaneous combination of atezolizumab and Halozyme's Enhanze technology, offering faster administration and expanded availability in the US.

Roche received FDA approval for OCREVUS ZUNOVO™, a subcutaneous formulation of ocrelizumab with Halozyme's ENHANZE® technology, for treating RMS and PPMS. The 10-minute SC injection offers treatment flexibility and optionality, supported by Phase III OCARINA II trial data showing non-inferior OCREVUS levels and comparable safety/efficacy to IV formulation.

The FDA approved Genentech’s Tecentriq Hybreza, the first PD-(L)1 inhibitor for subcutaneous administration, reducing injection time to about 7 minutes from 30-60 minutes for IV infusion. Tecentriq Hybreza combines Tecentriq with Halozyme’s Enhanze drug delivery technology, offering comparable efficacy and safety to the IV formulation, with 71% of patients preferring it for reasons like reduced clinic time and emotional distress.