HQ Team
August 30, 2023: Roche’s atezolizumab drug Tecentriq, to treat cancer, was approved by Britain’s Medicines and Healthcare Products Regulatory Agency.
Tecentriq can be administered subcutaneously (SC) or under the skin, in under seven minutes compared to 30-60 minutes taken by intravenous infusion (IV).
It is used to treat certain types of cancers, including lung, bladder, breast and liver cancer and is available on the National Health Service.
Multiple oncology studies suggested that the majority of cancer patients generally prefer SC over IV administration due to reduced discomfort, ease of administration and shorter duration of treatment.
Safety profile
“Cancer immunotherapy has transformed the way we treat cancer. Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer.
“We are working with health authorities globally to bring this option to many more patients around the world,” said Mr Garraway, who is also the Head of Product Development.
The MHRA regulatory approval came after data from final trials showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.
The MHRA, an executive agency of the Department of Health and Social Care, in the United Kingdom is responsible for the safety of medicines and medical devices.
Out-of-hospital
Tecentriq SC may be suitable for out-of-hospital administration by a healthcare professional, according to a company statement.
The medicine’s marketing authorisation application was currently under assessment by the European Medicines Agency, according to the statement.
Valuations by the US Food and Drug Administration and other health authorities globally were also been ongoing.
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
By inhibiting a monoclonal antibody called PD-1, Tecentriq enables the activation of immune cells in the body.
“Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers,” according to the statement.
Second largest cause of death
Tecentriq is also approved for some of the most aggressive and difficult-to-treat forms of cancer.
Cancer is a large group of diseases that can start in almost any organ or tissue of the body when abnormal cells grow uncontrollably, go beyond their usual boundaries to invade adjoining parts of the body and/or spread to other organs.
The latter process is called metastasizing and is a major cause of death from cancer. A neoplasm and malignant tumour are other common names for cancer.
Cancer is the second leading cause of death globally, accounting for an estimated 9.6 million deaths, or one in six deaths, in 2018, according to the WHO.
Lung, prostate, colorectal, stomach and liver cancer are the most common types of cancer in men, while breast, colorectal, lung, cervical and thyroid cancer are the most common among women.