FDA Approves New Immunotherapy Medicine for Specific Type of Advanced Bladder Cancer
May 18th, 2016
On May 18, the FDA granted accelerated approval to TECENTRIQ™ (atezolizumab) for 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).
The indication for TECENTRIQ is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
News in brief
- Accelerated approval allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit
- TECENTRIQ is the first and only anti-PDL1 cancer immunotherapy approved by the FDA
- TECENTRIQ is the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years
- Urothelial carcinoma is a type of bladder cancer that accounts for approximately 90 percent of the disease and can also be found in the renal pelvis, ureter and urethra
Supporting Information
“TECENTRIQ is a new medicine that can help work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy. We thank the scientists, doctors, patients and their families who made it possible to bring TECENTRIQ to people with advanced urothelial carcinoma.”