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Roche receives new EU approvals for cancer drug Tecentriq
Roche has announced that its cancer drug Tecentriq has been approved by the European Commission in a number of indications.
The treatment has been given the green light for use as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer following previous treatment with chemotherapy, regardless of PD-L1 status.
This approval was based on results from the phase III OAK study and the phase II POPLAR study, both of which showed that Tecentriq was able to help bolster survival rates among this patient group.
Additionally, the drug has been approved as a monotherapy for the treatment of people with locally advanced or metastatic urothelial carcinoma who have been previously treated with a platinum-containing chemotherapy or who are considered ineligible for such.
This was based on results from the phase III IMvigor211 study and the phase II IMvigor210 trial, which showed that Tecentriq produced strong response rates.
Dr Sandra Horning, Roche's chief medical officer and head of global product development, 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."
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