Genentech’s Bladder Cancer Drug Wins US Approval

Genentech has won an accelerated approval from the US Food and Drug Administration (FDA) for bladder cancer treatment Tecentriq. The immunotherapy has been cleared to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

The drug’s accelerated clearance was based on the tumour response rate and duration of response seen in a Phase II trial. However, continued approval may need to be verified in confirmatory trials.

Genentech is also evaluating Tecentriq in a confirmatory Phase III study. This trial compares the drug to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regime.

Bladder cancer is the fifth most commonly diagnosed cancer in the US and mUC accounts for 90% of all cases. Only 39% of people in advanced stages of the disease survive five or more years.