This morning, Merck KGaA and Pfizer Inc. announced that the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of avelumab (Bavencio).
The drug is to be used in a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC). In March, Bavencio was approved
by the U.S. Food and Drug Administration (FDA).
In mMCC, malignant cells form in the skin and soon spread to other areas of the body. Merkel cells are most commonly found in the top layer of the skin, or areas commonly exposed to the sun, like the head and neck.
"We welcome the CHMP's recommendation, as there are currently no approved treatments in Europe for this type of skin cancer, which can be devastating for patients and their families," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany said in a press release
"This is an important step towards making avelumab available to patients and we look forward to the European Commission's decision later this year."
Data from the JAVELIN Merkel 200 study assisted in formulating the positive opinion. The international, multicenter, single-arm, open-label, Phase II study was split into 2 parts:
Part A studied 88 patients with mMCC in which the disease had progressed after at least 1 chemotherapy treatment. 59% of patients reported to have had 1 prior anti-cancer therapy for mMCC and 41% had 2 or more prior therapies. Data submitted included a minimum of 18 months of follow-up.
Part B included 39 patients with histologically-confirmed mMCC who were treatment-naïve to systemic therapy in metastatic setting. 29 patients had at a minimum of 13 weeks of follow-up. Enrolment in Part B of the study is currently ongoing and planned to include 112 treatment-naïve patients.
Bavencio is a monoclonal antibody directed towards the protein death ligand -1 (PD-L1). By blocking the PD-1/PD-L1 pathway, the drug may assist in the body’s immune system attack of cancer cells. Common side effects of Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and swollen limbs.
It is expected that the European Commision (EC) will review the CHMP’s recommendation, and a decision is expected by the end of 2017.
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