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EMD Serono, Pfizer: FDA Approves SBLA For BAVENCIO

EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. (PFE) announced the US FDA has approved the supplemental Biologics License Application for BAVENCIO (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. The FDA has now converted the accelerated approval to full approval.

The FDA approval is based on results from the Phase III JAVELIN Bladder 100 study, which showed a significant 7.1-month improvement in median overall survival with BAVENCIO as first-line maintenance plus best supportive care, compared with best supportive care alone.

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