FDA on the Verge of Approving Merck Melanoma Treatment
Emery Dennel | | Aug 26, 2014 02:48 AM EDT |
(Photo : Reuters)
The U.S. Food and Drug Administration (FDA) may approve use of the melanoma drug "pembrolizumab" earlier than the scheduled October 28 deadline.
If approved, the drug made by Merck & Co. would be the first released to the public that uses the body's own immune system to combat melanoma.
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Melanoma is a type of skin cancer that causes existing moles to shift or change color. Or, in the case of nodular melanoma, new lumps appear on the skin.
Later stages of the disease see moles becoming itchy, ulcerating or bleeding.
The disease is believed to be primarily caused by genetics and by DNA being damaged by ultraviolet rays from the sun.
Merck's melanoma drug works by boosting the immune system so it's capable of fighting against and blocking the Programmed Death receptor (PD-1) protein or its relative (PD-L1).
Pembrolizumab has so far proven to have had encouraging late-study results. Tumors were reduced in one-third of the patients involved in the study.
Melanoma is diagnosed through a skin biopsy where the physician makes incisions on the scar or tumor.
The most common method of removing tumors is through excisional biopsies followed by further surgery to decrease the likelihood of recurrence.
Melanomas that spread first target the lymph nodes in the area where the tumor is located before spreading to other parts of the body.
Despite claims of an early approval by the FDA, anything is still possible because the drug's usage of the body's immune system to destroy cancer cells may lead to very severe side effects. More testing might be required.
On the other hand, Bristol-Myers Squibb is currently offering Yervoy, an immunotherapy based treatment that targets a different part of the immune system.
For patients who don't see results with Yervoy, using pembrolizumab may prove to be beneficial.
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