Swiss pharmaceutical company Roche has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Tecentriq (atezolizumab), to treat locally advanced or metastatic urothelial carcinoma (mUC).
The drug can be administered on patients whose disease has progressed during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy either before surgery (neoadjuvant) or after surgery (adjuvant).
Urothelial carcinoma is a serious cause for all bladder cancers and can be found in the ureter, renal pelvis and urethra.
Tecentriq is a monoclonal antibody that can directly bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, thereby preventing its interactions with both PD-1 and B7.1 receptors.
Atezolizumab can allow the activation of T cells by inhibiting PD-L1.
Roche global product development head and chief medical officer Sandra Horning said: "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.
"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 programme facilitates conditional approval of a medicine that meets an unmet medical need for a serious condition, which is dependent on early evidence suggesting clinical benefit.
The current FDA approval of Tecentriq is based on the Phase II IMvigor 210 study.
Image: Histopathology of bladder urothelial carcinoma. Photo: courtesy of KGH