European approval of licence extension of avelumab (Bavencio) for first-line maintenance treatment of advanced or metastatic urothelial carcinoma
The licence extension as monotherapy, is based on results of the JAVELIN Bladder 100 trial which demonstrated improved overall survival with avelumab plus best supportive care vs best supportive care alone (21.4 vs 14.3 months; HR 0.69; 95% CI: 0.56 to 0.86).
Source:
Biospace Inc.
SPS commentary:
Based on these data, the avelumab first-line maintenance regimen has been added to the recently updated ESMO Clinical Practice Guidelines for bladder cancer.