FDA Grants Roche’s Cancer Immunotherapy Tecentriq Accelerated Approval

Roche has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) for the treatment of people 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 surgery (neoadjuvant) or after surgery (adjuvant).

Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. “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,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.

“We thank the scientists, doctors, patients and their families who made it possible to bring Tecentriq to people with advanced urothelial carcinoma.” The FDA’s Accelerated Approval Program 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. approval of Tecentriq is based on the phase II IMvigor 210 study. Roche is also evaluating Tecentriq in a confirmatory phase III study (IMvigor 211), which compares Tecentriq to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.