Merck KGaA’s cancer drug Bavencio gets EU approval

pharmafile | January 25, 2021 | News story | Sales and Marketing Merck KGaA 

The EC has approved Merck KGaA’s BAVENCIO (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.

In the pivotal JAVELIN Bladder 100 trial, BAVENCIO plus best supportive care (BSC) as first-line maintenance demonstrated a significant improvement in median overall survival (OS) compared with BSC alone at the prespecified interim analysis: 21.4 months versus 14.3 months in the coprimary population of all randomised patients. In the coprimary population of patients with PD-L1+ tumours, OS was also significantly longer with BAVENCIO plus BSC compared with BSC alone. Based on these data, the BAVENCIO first-line maintenance regimen was added to the recently updated ESMO Clinical Practice Guidelines for bladder cancer.

Updated OS results also showed BAVENCIO significantly extended OS among all randomised patients compared with BSC alone, with median OS of 22.1 months versus 14.6 months, respectively.

BAVENCIO was first approved in the US as a first-line maintenance treatment for advanced UC by the FDA in June last year, and is now approved for this indication in 38 countries. Additional regulatory applications are under review in 13 countries.

Rehan Verjee, President of EMD Serono and Global Head of Innovative Medicine Franchises for the Healthcare business sector of Merck KGaA in Darmstadt, Germany, said: “This approval allows us to extend the reach of BAVENCIO to even more patients with bladder cancer and offer the hope of extended survival. This is a clear demonstration of our commitment to transform standards of care in cancer.”

Professor Thomas Powles, Director of Barts Cancer Centre in London, added: “Avelumab is the only immunotherapy to demonstrate a significant improvement in overall survival in the first-line setting in a Phase III study in advanced or metastatic bladder cancer. With this approval by the European Commission, we can now offer patients a potential new first-line maintenance standard of care that may help them live longer.”

Darcy Jimenez

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