Roche has received approval from the US Food and Drug Administration for Tecentriq Hybreza.
The combination of atezolizumab and hyaluronidase-tqjs is the first and only PD-(L)1 inhibitor currently available on the market that is suitable for subcutaneous (SC) administration.
The infusion takes significantly less time than the traditional intravenous (IV) administration of Tecentriq, enhancing the patient centricity of the therapeutic.
The approval was awarded based on data from the Phase IB/III IMscin001 study, which showed comparable levels of the drug in the blood when it was administered subcutaneously compared to IV.
71% of patients also preferred the subcutaneous format, owing to the reduced time in the clinic, increased comfort during treatment and a reduction in treatment-associated emotional distress.
79% of patients then chose to switch to Tecentriq Hybreza when given the choice between the SC and IV iteration of the drug.
Roche's Chief Medical Officer and Head of Global Product Development, Levi Garraway, commented: “By enabling subcutaneous administration for a 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.”
“This approval represents a significant option to improve the patient experience,” said Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation.
“When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option."