Roche wins European recommendation for Tecentriq
The Roche pharmaceutical group has gained a key endorsement of the use of its cancer immunotherapy treatment Tecentriq in Europe.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued its recommendation for the subcutaneous administration of Tecentriq in the treatment of several types of cancer.
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If approved by the regulator, the monoclonal antibody developed by the Basel-based company would be the first injectable PD-L1 immunotherapy available in the European Union (EU), with the potential to reduce treatment times by around 80%.
“Subcutaneous administration offers a faster, more convenient alternative to intravenous infusion,” said Levi Garraway, Head of Medical Research and Product Development at Roche, quoted in a press release on Tuesday. To date, Tecentriq has been used to treat over 430,000 people with some of the most aggressive forms of cancer.
The CHMP’s recommendation is based on data from the pivotal Phase IB/III IMscin001 study of 371 patients, which demonstrated a similar level of efficacy for subcutaneous versus injectable treatment.
Tecentriq is currently approved in many countries as a primary treatment or in combination with other therapies to treat various types of disease, including certain types of lung, liver, bladder and breast cancer.
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