Who makes bavencio?
Bavencio is made by EMD Serono, Inc., a pharmaceutical company located in Rockland, Massachusetts, USA. You can contact EMD Serono by calling +1-800-283-8088 or contact them online. In March 2017, the U.S. Food and Drug Administration (FDA) approved Bavencio (avelumab) injection.
How is Bavencio approved in the United States? BAVENCIO is a human programmed death ligand-1 (PD-L1) blocking antibody indicated in the US for the treatment of adults and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma.1 This indication is approved under accelerated approval based on tumor response and duration of response.
How old do you have to be to take Bavencio? Bavencio is used to treat a type of skin cancer called Merkel cell carcinoma (MCC) in adults and children at least 12 years old, when the cancer has spread to other parts of the body (metastatic).
What kind of cancer does Merck Bavencio treat? Merck and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO ® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.
Is the Merck Bavencio monotherapy approved in Europe? Merck and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally
How did Bavencio get approved by the FDA?
How did Bavencio get approved by the FDA? BAVENCIO was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
How many patients were enrolled in the Bavencio clinical trial? The FDA approved BAVENCIO based on evidence from one clinical trial of 88 patients with metastatic MCC and whose tumor was no longer responding to chemotherapy. The trial was conducted in North America, Western Europe, Australia and Asia. Figure 1 summarizes how many men and women were enrolled in the clinical trial.
How does Bavencio work to treat skin cancer? Bavencio targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Bavencio may help the body’s immune system attack cancer cells.
How often do you give Bavencio 10 mg / kg? Patients received BAVENCIO 10 mg/kg as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.