Roche’s Tecentriq scores approvals in metastatic lung and bladder cancer
pharmafile | September 27, 2017 | News story | Research and Development, Sales and Marketing | Cancer, EMA, EU, European Commission, Roche, bladder cancer, immunotherapy, lung cancer, pharma, tecentriq
It’s good news for Roche as the company’s immunotherapy drug Tecentriq secures approval from the European Commission to be used in the treatment of metastatic non-small cell lung cancer (NSCLC) and two forms of metastatic bladder cancers.
Specifically, the drug has been approved in previously treated locally advanced or metastatic NSCLC, and in metastatic urothelial carcinoma (mUC) in those who have received a platinum-based chemotherapy or who are ineligible to receive cisplatin chemotherapy.
The decision in NSCLC was based on data generated from a Phase 2 and Phase 3 trial which demonstrated that Tecentriq enabled patients to live longer than those receiving docetaxel chemotherapy.
In mUC, the approval decision was influenced by the findings of Phase 2 and 3 trials which found that Tecentriq increased median duration of response to 21.7 months versus 7.4 months with chemotherapy. Interestingly, the Phase 3 trial in question failed to meet its primary endpoint of overall survival.
Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, said: “The totality of the data for Tecentriq across all indications including long-term responses in advanced bladder cancer and the overall survival advantage observed in our Phase III advanced lung cancer study means that we are able to extend the benefits of Tecentriq to people living with these types of cancer regardless of their levels of PD-L1 expression.”
The drug is already approved in the US, but was rejected by NICE in August based on cost concerns, though the regulator did ask Roche to submit a proposal for Tecentriq to be included on the Cancer Drugs Fund.
Matt Fellows
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