FDA grants accelerated approval to Tecentriq (atezolizumab) for metastatic urothelial carcinoma.-Genentech + Roche

Genentech, announced that the 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 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

Comment: Bladder cancer is the fifth most commonly diagnosed cancer in the United States.

Comment: A marketing advantage for Tecentriq is in its benefits to patients who test positive for the PD-L1 biomarker. The drug specifically targets PD-L1, rather than PD-1 which are the focus of both Opdivo and Keytruda and Roche sees the PD-L1 target as having a more significant effect on the disease. Therefore the drug may have a good chance of showing a more durable effect on cancer than its competitors with a lower likelihood of toxicity.