FDA approves Pfizer, German Merck immunotherapy for skin cancer stat : Reuters

While most cases are treated with surgery, more than 30 percent eventually see the Cancer spread, the FDA said. It marks the first immunotherapy approval for the collaboration of Pfizer and Germany-based Merck, which has been playing catch-up with rivals, such as Bristol-Myers Squibb Co, Merck & Co and Roche Holding AG . U.S. health regulators on Thursday approved a addiction developed by Merck KGaA and Pfizer Inc that helps the immune system to fight a rare form of skin cancer once it has spread to other parts of the body. About 1,600 people in the United States are diagnosed with MCC every year, according to the National Cancer Institute. The Food and Drug Administration said it approved Bavencio, known chemically as avelumab, to treat metastatic Merkel cell carcinoma (MCC) in patients 12 years and older.




This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. In patients with metastatic MCC, the cancer has spread beyond the skin into other parts of the body. These advancements are leading to new therapies-;even in rare forms of cancer where treatment options are limited or non-existent." Of the 88 patients who received Bavencio in the trial, 33 percent experienced complete or partial shrinkage of their tumors. Bavencio also received Orphan addiction designation, which provides incentives to assist and encourage the development of drugs for rare diseases.


This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. In patients with metastatic MCC, the cancer has spread beyond the skin into other parts of the body. "The scientific community continues to make advances targeting the body's immune system mechanisms for the treatment of various types of cancer. Of the 88 patients who received Bavencio in the trial, 33 percent experienced complete or partial shrinkage of their tumors. Bavencio also received Orphan addiction designation, which provides incentives to assist and encourage the development of drugs for rare diseases.


collected by :Lucy William

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