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Pfizer's (PFE) Bavencio Gets EU Nod for First-Line Bladder Cancer

Pfizer Inc. PFE along with Germany’s Merck KGaA announced that the European Commission (“EC”) has approved their PD-L1 inhibitor, Bavencio (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced/metastatic urothelial carcinoma (“UC”) who remain progression-free following platinum-based chemotherapy.

We note that Bavencio is already approved for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or in other words, for second-line use.

The approval in EU for this expanded indication was based on data from the phase III JAVELIN Bladder 100 study which evaluated Bavencio plus best supportive care (“BSC”) in the given patient population.

Data from the study showed that Bavencio as first-line maintenance treatment led to a significant improvement in median overall survival (“OS”) versus BSC alone. Per the company, Bavencio is the first and only immunotherapy to demonstrate a significant OS benefit in the first-line setting in a phase III study for advanced/metastatic UC, the most common form of bladder cancer.

Based on the above data, the Bavencio first-line maintenance regimen has been recommended for use by the ESMO Bladder Cancer Guidelines.

Per the press release, despite available treatments, an estimated 204,000 people were diagnosed with bladder cancer across Europe in 2020, which resulted in more than 67,000 deaths from the disease. The five-year survival rate is 5% for patients diagnosed with metastatic UC.

Hence, following the approval by the EC, Bavencio can now be given to patients as a potential new first-line maintenance standard of care.

Bavencio was approved in the United States for first-line maintenance treatment for advanced UC in June last year.

Additionally, Bavnecio is approved for use in combination with Pfizer’s Inlyta for first-line treatment of advanced kidney cancer and for Merkel cell carcinoma. Although Bavencio is currently approved for three relatively smaller indications, it might emerge as a key long-term driver for Pfizer on future label-expansion approvals.

However, Bavencio faces stiff competition from other approved PD-L1 inhibitors in the market, such as Merck’s MRK blockbuster drug Keytruda (pembrolizumab), Bristol-MyersBMY Opdivo (nivolumab) and AstraZeneca’s AZN Imfinzi (durvalumab).

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