Melanoma Drug Approved By FDA For Expanded Use

The highly recommended viral drug therapy for cancer, chemically known as talimogene laherparepvec or T-vec has been approved by the United States Food and Drug Administration after further investigation of the drugs and following the favorable recommendation of the drug by the European Union drug reviewers.

The drug which had a high effectiveness in its clinical trial, with over 951 patients tested with the drugs. The drug was shown to be very safe and largely effective.

The drug therapy also offers a two pronged approach for the treatment of metastatic melanoma, Dr. Butterfield said in a memo.

"This new use of the drug in earlier stages of the disease builds on our understanding of the immune system's interaction with cancer", Richard Pazdur, MD, the director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, admitted.

The viral drug therapy works like this: the drug enters a cell and it takes over the host's DNA replication system and it starts to replicate copies of itself.

The virus also contains a human gene to make granulocyte macrophage colony-stimulating factor (GM-CSF), which aims to cause anti-tumor immune response in the patient.

The drug (Yervoy) helps the body's immune system recognize and attack melanoma cancer cells, while Imyglic must be injected directly into the melanoma lesions, which ruptures and introduces antigens.

Imyglic is a genetically modified herpes virus and is approved to be used for melanoma that cannot be completely removed through surgery.

The viral drug is a collaborative project by Amgen, which is the manufacturer of the T-vec. The new drug will be sold under the name of IMLYGICTM.

Amgen is also aiming to study more into treatments that combine other immunotherapy drugs to learn if it can improve the survival rates of cancer patients.

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