FDA approves Pfizer and Merck KGaA’s Bavencio for maintenance of advanced bladder cancer
pharmafile | July 1, 2020 | News story | Research and Development, Sales and Marketing | Bavencio FDA, EMD Serono, Merck, Pfier
The FDA has moved to approve Bavencio (avelumab), developed by Pfizer and EMD Serono, the biopharma arm of Merck KGaA, as a maintenance therapy for the treatment of locally advanced or metastatic urothelial carcinoma (UC) which hasn’t progressed following first-line platinum-containing chemotherapy.
In Phase 3 trials, Bavencio generated a median overall survival (OS) of 21.4 months when combined with best supportive care (BSC), a 7.1 month improvement over BSC alone, meaning it reduces the risk of death by 31% in the overall population. This data was used to secure this latest US approval.
“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” commented Dr Petros Grivas, a principal investigator on the Phase 3 trial. “With median overall survival of more than 21 months measured from randomization, the longest overall survival in a Phase3 trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”
Due to its high initial response rate, platinum-based chemo is currently the first-line standard of care for this indication, but the majority of patients receiving it are observed to see their disease progress within nine months regardless, with only 5% of patients diagnosed with metastatic disease surviving for longer than five years. In patients who do not see disease progression, Bavencio can be used until either disease progression or unacceptable toxicity occurs.
“With this approval for Bavencio, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer,” added Rehan Verjee, President of EMD Serono and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck KGaA. “Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice.”
Matt Fellows
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