Roche’s drug scores expanded FDA indication in advanced bladder cancer
pharmafile | April 18, 2017 | News story | Manufacturing and Production, Sales and Marketing | Genentech, Roche, tecentriq
Roche’s Genentech has revealed that its immunotherapy drug Tecentriq (atezolizumab) is now enjoying an expanded indication in the US after approval by the FDA for advanced bladder cancer – specifically the treatment of adult patients for locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
The therapy has already seen approved by the FDA for advanced bladder cancer in patients have experienced disease progression within one year of receiving platinum-based chemotherapy; it was originally granted accelerated approval for the indication back in May 2016.
Urothelial carcinoma accounts for nine out of ten bladder cancer cases, and as many as half of all patients suffering from the disease are not eligible for cisplatin chemotherapy as treatment. The news of this expanded indication is significant as it opens a new door in a region of unmet medical need.
Sandra Horning, CMO and Head of Global Product Development, commented: “We are pleased that Tecentriq will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy. Tecentriq was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose disease has progressed after receiving other medicines, either before or after surgery, or after their disease has spread.”
Matt Fellows
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