FDA Approves Roche's Injectable PD-L1 Inhibitor for Various Cancers

Roche’s new injectable PD-L1 inhibitor, Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), recently received approval from the US Food and Drug Administration (FDA) for treating various types of cancer. This subcutaneous (SC) formulation combines Tecentriq (atezolizumab) with Halozyme Therapeutics’ Enhanze drug delivery technology, enabling it to be administered in approximately seven minutes. This is a significant improvement compared to the 30 to 60 minutes required for a standard intravenous (IV) infusion of the drug.

Tecentriq Hybreza’s FDA approval marks it as the first and only SC anti-PD-L1 cancer immunotherapy available in the United States. This approval extends to all adult indications for which the IV version of the drug has previously been approved. These indications include certain types of lung, liver, skin, and soft tissue cancers.

The FDA’s decision was supported by findings from the phase 1b/3 IMscin001 study. This study demonstrated that when administered subcutaneously, Tecentriq achieved comparable levels in the bloodstream as the IV form. Additionally, the safety and efficacy profiles were consistent between both formulations. Notably, 71% of patients expressed a preference for Tecentriq Hybreza over the IV version, citing reasons such as shorter clinic visits, enhanced comfort during the treatment, and reduced emotional distress.

Levi Garraway, Roche’s chief medical officer and head of global product development, highlighted the benefits of the new SC formulation. He stated, “By enabling SC 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 SC formulation that builds on the established safety and efficacy profile of IV Tecentriq and can treat patients faster and in more accessible settings.”

The US approval of Tecentriq Hybreza comes just over a year after NHS England announced that it would be the first health system globally to offer Tecentriq SC to eligible patients, following approval from the Medicines and Healthcare products Regulatory Agency. Since then, the SC formulation has been approved in over 50 countries, with regulatory reviews ongoing in additional countries and regions.

Ann Fish-Steagall, senior vice president of patient services at the LUNGevity Foundation, emphasized the importance of this new approval. She remarked that the latest approval “represents a significant option to improve the patient experience.” She added, “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option.”

Overall, the approval of Tecentriq Hybreza provides a significant advancement in cancer treatment, offering a more convenient and patient-friendly alternative to traditional IV infusions. This development underscores the importance of patient-centered approaches in medical advancements, giving patients more control over their treatment experience.