Updated on 15 March 2016
Atezolizumab is granted priority review designation by FDA
Singapore: US Food and Drug Administration (FDA) has accepted Biologics License Application (BLA) and granted Priority Review for Genentech's atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC).
The drug is indicated for people with mUC who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease 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
Atezolizumab was granted Priority Review designation based on results of the IMvigor 210 study, which showed the medicine shrank tumors in a type of advanced bladder cancer, and the majority responding to treatment continued to respond after nearly a year of follow up," said Dr 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."
A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Atezolizumab was 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). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results of the IMvigor 210 Phase II study, and the FDA will make a decision on approval by Sept. 12, 2016. Atezolizumab is also being studied in a number of other cancers.