The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.
The treatment offers a quicker and more comfortable administration option compared to the standard intravenous infusion.
Tecentriq Hybreza is administered in seven minutes, as against the 30 to 60-minute duration required for the intravenous version of Tecentriq.
This new formulation is set to be available for all of Tecentriq's intravenous indications approved for adults in the US, including specific types of liver, lung, skin and soft tissue cancer.
The FDA's decision was informed by data from the Phase IB/III IMscin001 clinical trial, which demonstrated that Tecentriq Hybreza achieved comparable blood levels to the intravenous formulation and maintained a consistent safety and efficacy profile.
Findings from the Phase II IMscin002 study indicated a strong patient preference for Tecentriq Hybreza over intravenous atezolizumab, with 71% of patients favouring the subcutaneous option.
The primary reasons cited were reduced clinic time, increased comfort during treatment and less emotional distress.
79% of patients opted to continue their treatment with Tecentriq Hybreza after experiencing both formulations.
The therapy combines the active ingredient Tecentriq with Halozyme Therapeutics' Enhanze drug delivery technology to enhance the administration process.
Tecentriq operates by targeting PD-L1, a protein found on tumour cells and tumour-infiltrating immune cells, to disrupt its interaction with PD-1 and B7.1 receptors.
This inhibition may reactivate T cells and allow the immune system to better target cancer cells, although it may also impact normal cells.
Roche global product development head and chief medical officer Levi Garraway stated: “By enabling subcutaneous administration for cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration.
“We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients faster and in more accessible settings.”
In August 2024, the company received the European Commission (EC) approval for PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adult and adolescent patients.
