US FDA accepts Roche’s supplemental biologics licence application
?The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics Licence Application (sBLA) and granted priority review for Tecentriq (atezolizumab) to treat people with locally advanced or metastatic urothelial carcinoma (mUC).
Tecentriq can be given to people who are not eligible for cisplatin chemotherapy, and are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before or after surgery.
mUC accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.
Roche chief medical officer and global product development head Dr Sandra Horning said: “In May 2016, Tecentriq became the first treatment approved by the FDA for people with previously treated advanced bladder cancer in more than 30 years.
“We are committed to continue working with the FDA to make tecentriq available to more people with this type of advanced bladder cancer, specifically those who are unable to tolerate cisplatin-based chemotherapy as an initial treatment.”
The company’s sBLA submission for Tecentriq is based on results from the Phase II IMvigor210 open-label, multicentre, single-arm Phase II study.
As part of this study, the safety of Tecentriq has been evaluated in people with locally advanced or mUC, regardless of PD-L1 expression.
The FDA is set to make a decision for approval by 30 April this year.
Tecentriq is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death-ligand 1), which is expressed on tumour cells and tumour-infiltrating immune cells.