FDA grants accelerated approval for Roche’s bladder cancer immunotherapy Tecentriq

pharmafile | May 19, 2016 | News story | Research and Development, Sales and Marketing FDA, Roche, atezolizumab, bladder cancer, immunotherapy, tecentriq 

Roche (SIX: RO) has announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Tecentriq (atezolizumab) for the treatment of patients with a specific type of bladder cancer.

The drug is indicated for patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during of following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery or after surgery. Urothelial carcinoma accounts for 90% of all bladder cancers.

Under an accelerated approval, the FDA allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early clinical signs showing safety and efficacy. This approval is based on the Phase II IMvigor study, which achieved objective response rates of 14.8% across all patients. Roche is set to evaluate the drug in a Phase III study.

Sandra Horning, chief medical officer at Roche, says: “Tecentriq is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy.”

Sean Murray

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