The European Commission (EC) has approved Merck and Pfizer’s Bavencio (avelumab) for the maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) – the most common type of bladder cancer.
The approval is supported by data from the JAVELIN Bladder 100 trial, in which Bavencio on top of best supportive care (BSC) demonstrated a significant improvement in median overall survival compared to BSC alone.
Bavencio plus BSC treated patients demonstrated median OS of 21.4 months compared to 14.3 months in the co-primary population of all randomised patients.
In another population, containing patients with PD-L1-positive tumours, patients treated with Bavencio plus BSC also demonstrated significantly longer OS compared to BSC alone.
Updated OS results – with a data cut-off of 19 January 2020 – also showed Bavencio significantly extended OS among all patients compared to BSC alone with a median OS of 22.1 months versus 14.6 months respectively.
“This approval by the EC addresses an urgent unmet need, and we look forward to providing a new treatment option for people in Europe with locally advanced or metastatic urothelial carcinoma,” said Andy Schmeltz, global president, Pfizer Oncology.
“This approval allows us to extend the reach of Bavencio to even more patients with bladder cancer and offer the hope of extended survival,” said Rehan Verjee, president of North America and global head of Innovative Medicine Franchises for the Healthcare business sector of Merck.
“This is a clear demonstration of our commitment to transform standards of care in cancer,” he added.
In June 2020, the US Food and Drug Administration (FDA) approved Bavencio as a first-line maintenance treatment for advanced UC, with additional regulatory applications currently under review in another 13 countries.