ZURICH (Reuters) - Roche immunotherapy Tecentriq has won European Union approval for treating advanced lung and bladder cancer, the Swiss drugmaker said.
The European Commission approved Tecentriq, also known as atezolizumab, as a monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after patients have been treated with chemotherapy.
The Commission also approved the drug as a monotherapy for treating people with locally advanced or metastatic urothelial carcinoma (mUC) who have been treated with a platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, Roche said.
“We are delighted that the European Commission has approved Tecentriq, the first anti-PD-L1 cancer immunotherapy approved in the EU, as a monotherapy in both advanced bladder and advanced lung cancer,” chief medical officer Sandra Horning said in a statement late on Friday.
The therapy is already approved in the United States and several other countries for people with metastatic NSCLC, people with mUC who are not eligible for cisplatin chemotherapy, or those whose disease progresses during or after platinum-containing therapy.
Roche is counting on the immunotherapy to help offset the loss of sales from biologic cancer drugs facing cut-throat competition from so-called biosimilar rivals.
It generated first-half sales of 237 million Swiss francs ($245 million).
Reporting by Michael Shields; Editing by Andrew Bolton