Shots:

• The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg- IV infusion- q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
• Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population- in PD-L1+ patients (44% reduction in risk of death)- in an exploratory analysis of patients with PD L1 negative tumors- OS hazard ratio (0.85)
• Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program- following the receipt of BT designation. In 2017- the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval

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Ref: Pfizer | Image: Merck KGaA