MHRA gives OK to Bavencio for first-line maintenance of advanced bladder cancer via the Early Access to Medicines Scheme

It has been revealed that Bavencio (avelumab), jointly developed by Merck KGaA and Pfizer, has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for use via the Early Access to Medicines Scheme (EAMS) in the first-line treatment of advanced or metastatic bladder cancer, after confirming a positive benefit-risk profile for the therapy.

Specifically, the approval concerns the first-line maintenance of locally advanced or metastatic urothelial carcinoma in patients whose disease has not progressed after receiving first-line platinum-containing chemotherapy.

Phase 3 data in support of the decision was gathered from patients after they had received four to six cycles of best supportive care (BSC) – either gemcitabine plus cisplatin or carboplatin chemotherapy – over a four-month period. It was shown that, when combined with BSC, Bavencio extended median overall survival (OS) by 7.1 months to 21.4 months, compared to when it was used as a monotherapy, representing a reduction of 31% in risk of death among the examined patient population.

In patients who receive platinum-based chemotherapy alone as BSC in this indication, many see their disease progress within nine months of the initial dose, while the survival rate of five years or more with metastatic disease is just 5%.

“Bladder cancer is the eleventh most common cancer in the UK, with urothelial carcinoma being the most common type of bladder cancer, accounting for 90% of all cases,” explained Dr Mike England, Medical Director at Merck UK & Ireland. However, treatment options are limited and survival rates are poor. Therefore, we are delighted by the MHRA’s positive decision to provide early access to avelumab, as there is a significant unmet need in this therapy area for new treatment options for these patients. We believe this is a major advance in the existing standard of care and will improve patient outcomes.”

Matt Fellows