Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer
pharmafile | March 15, 2016 | News story | Manufacturing and Production, Research and Development | FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review
The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease progressed after chemotherapy.
The specific indication is for urothelial carcinoma, which accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.
“Atezolizumab was granted Priority Review designation based on results of the IMvigor 210 study, which showed the medicine shrank tumours in a type of advanced bladder cancer, and the majority responding to treatment continued to respond after nearly a year of follow up,” comments Sandra Horning, chief medical officer and head of Global Product Development. “The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible.”
The Priority Review status for atezolizumab, formerly known as MPDL3280A, follows the drug being granted Breakthrough Therapy Designation by the FDA in May 2014 for the treatment of people whose metastatic bladder cancer expresses the protein PD-L1 (programmed death ligand-1).
In January 2016, Roche revealed Phase II trial data showing that 84% of people who responded to atezolizumab (also known as MPDL3280A) continued to respond regardless of their PD-L1 status
The FDA is set to make a decision on the drug’s approval by September 12, 2016, based on the results of this Phase II trial, IMvigor 210. Atezolizumab is also being studied in a number of other cancers.
Joel Levy
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