Regulatory Affairs

Merck, Pfizer get EC approval for skin cancer drug Bavencio

PBR Staff Writer Published 22 September 2017

Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.

Bavencio, which is intended to be delivered intravenously, is a human antibody designed to inhibit the programmed death ligand-1 (PD-L1) protein. It has been developed to potentially engage the adaptive and innate immune systems.

According to Pfizer, Bavencio is thought to stop tumor cells from using PD-L1 for protection against white blood cells like T cells while exposing them to anti-tumor responses.

The marketing authorization from the regulator paves way for the launch of the prescription drug in the European Union (EU) in the coming months. Initially, the mMCC drug will be launched in Germany and the UK as early as next month.

Merck biopharma business executive vice president, research and development global head Luciano Rossetti said: “The EC's decision is significant for BAVENCIO and, more importantly, for European patients living with this very challenging skin cancer.

"Our alliance with Pfizer continues to demonstrate the power of working together, and we are grateful to everyone who has helped to bring the first and only approved immunotherapy for mMCC to European patients.”

Bavencio’s approval in EU is based on the findings of a phase 2 study with two parts named as JAVELIN Merkel 200.

The objective response rate of Bavencio was 33% in the Part A study featuring 88 patients with mMCC whose disease had progressed following one or more chemotherapy treatments.

Bavencio showed an objective response rate of 62% in the Part B study featuring 39 patients with histologically confirmed mMCC who did not undergo systemic therapy in the metastatic setting.

Pfizer oncology global president Liz Barrett said: “This European approval further establishes our continued momentum, building on the accelerated approvals BAVENCIO received in the US earlier this year.

“Importantly, we are now one step closer to our goal of making BAVENCIO available to patients around the world.”

The US Food and Drug Administration (FDA) had approved Bavencio (avelumab) injection 20 mg/mL in March for the treatment of mMCC.

Image: Bavencio is the first FDA-approved immunotherapy for metastatic Merkel cell carcinoma. Photo: courtesy of PRNewswire / EMD Serono, Inc.