FDA grants fast review for Genentech’s bladder cancer drug atezolizumab
The US Food and Drug Administration (FDA) has granted priority review to Genentech’s advanced bladder cancer drug, atezolizumab.
The Roche unit said yesterday that the FDA is set to make a regulatory decision on atezolizumab before 12 September, for locally advanced or metastatic urothelial carcinoma, where disease progressed during or following platinum-based chemotherapy in the metastatic setting, or if disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
After granting a priority review, for drugs which offer major advances or provide a treatment where none existed, the FDA seeks to make regulatory decisions within six months as opposed to the standard review time of 10 months.
Atezolizumab was granted priority review based on results of the phase 2 IMvigor 210 study, said Sandra Horning, chief medical officer and head of global product development at Genentech.
The drug was also granted breakthrough therapy designation to expedite its development, Genentech noted.
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