FDA Approves New Option for Certain People with Advanced Bladder Cancer
April 17th, 2017
On April 17, the FDA granted accelerated approval to TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. TECENTRIQ was previously approved for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). It is not known if TECENTRIQ is safe and effective in children.
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
- First and only cancer immunotherapy approved as initial treatment for people with advanced bladder cancer not eligible to receive cisplatin chemotherapy
- Up to half of all people with advanced bladder cancer are unable to receive cisplatin chemotherapy as an initial treatment
- 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
“We are pleased that TECENTRIQ will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy. TECENTRIQ was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose cancer progressed after receiving other medicines, either before surgery or after surgery, or after their disease has spread.”