EU medical health procedures

European Commission Approves Marketing of Bavencio

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The European Commission has granted Merck and Pfizer Inc. (PFE) authorization to market a treatment for patients that suffer from metastatic Merel cell carcinoma. The monotherapy treatment, Bavencio, is offered to treat an aggressive and rare form of skin cancer.

Bavencio is able to be marketed in 28 countries in the Eurozone, including Iceland, Norway, and Liechtenstein. The treatment is expected to launch as early as October in Germany and the United Kingdom. Commercial availability of Bavencio is expected to come in the next few months.

“The EC’s decision is significant for BAVENCIO and more importantly, for European patients living with this very challenging skin cancer,” said Luciano Rossetti, M.D. of Merck.

The treatment was also approved in the United States earlier in the year. The company’s goal is to make the drug available worldwide. The company estimates that 2,500 patients in the European Union are diagnosed with Merel cell carcinoma each year.

The survival rate is slim, with less than 20% of patients living beyond the 5-year mark.

European Commission approval is based on two main parts. The first part includes a study of 88 patients, all of which suffered from cancer. Some 93% of tumors responded to the treatment for at least six months. The study found that 71% responded to the treatment for 12 months or more.

Safety testing on the drug included 1,738 patients that had solid tumors. These patients received treatment every two weeks based on their weight. The study found that the most prominent adverse side effect was fatigue, which was experienced by 32.4% of the participants. Nausea, diarrhea and decreased appetite were among the most common side effects experienced.

Swissmedic also granted Merck and Pfizer the right to market the treatment on September 5, 2017. The approval is only granted to persons that have had at least one chemotherapy treatment in which the disease continued to progress.

The treatment, also known as Javelin, includes 30 clinical programs and more than 6,300 patients. Clinical programs have been conducted on an array of tumor types, including melanoma, mesothelioma, ovarian, urothelial carcinoma and non-small cell lung cancer.

Efficacy of Bavencio was demonstrated during a Phase II, open-label study.

The first part of the study included 0.59% of patients that had at least one anti-cancer therapy for the disease.

Patients that had central nervous system metastasis, CNS, were excluded from the trial. Patients that also have active or history with the autoimmune disease, immune suppression, HIV, hepatitis B or C or organ transplants were also excluded from the trial.

The treatment was provided via intravenous infusion every two weeks for 60 minutes. The treatment continued until the disease progressed further. Patients were also evaluated for unacceptable levels of toxicity.

If the patient’s toxicity levels reached levels higher than the acceptable amount, the treatment was halted.

The treatment is an antibody that is specific for PD-L1. The antibody is thought to bind to white blood cells and expose them to anti-tumor responses. Merck and Pfizer both announced an alliance to co-develop the treatment in November 2014.

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