The US Food and Drug Administration (FDA) have granted accelerated approval to Genentech’s medication to treat people with bladder cancer
Genentech’s Tecentriq is for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy.
The FDA’s Accelerated Approval Programme allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit.
The indication for Tecentriq is approved under accelerated approval based on tumour response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Sandra Horning, chief medical officer and head of global product development at Genetech, said: “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.
Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network, said: "Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers.
“Tecentriq is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options.”
Information on the possible side effects of Tecentriq are available online.