FDA APPROVES MERCK DRUG KEYTRUDA FOR MELANOMA IMMUNOTHERAPY

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On Thursday, September 4, 2014, the American pharmaceutical company Merck (Merck and Co) stated that the Office of the quality control of products and medicines USA (Food and Drug Administration, FDA) approved the utilize of its medicine Keytruda for the cure of patients with severe or acute melanoma.

The medicine is proposed for the healing of unresectable or sever melanoma in patients who were cured before ipilimumab (ipilimumab). This medicine therapy has been approved for patients based on the results of a clinical study of 162 patients. A Merck drug for melanoma is clinically tested in laboratory by various microbiologist and they found this drug effective against melanoma.

fda-approved-merck-drug-keytrude

Melanoma is the mainly the destructive type of skin cancer and the leading reason of death from skin disease. The main problem is that this disease cannot be surgically eliminated and it has been treated with medicines in the earlier time period. But due to the severeness of this disease all the drugs were low effective.

The most ordinary side effects reported by tolerant receiving double therapy, it – fever, chills, exhaustion, itchiness, vomiting, diarrhea, abdominal pain, swelling of the hands and feet, cough, annoyance, joint pain, night sweating, decreased hunger, constipation, and pain in the muscles. Severe side effects include: bleeding, blood clot, heart failure, skin problems and eye and kidney failure. Women of childbearing age should be alert that can cause birth defects and abnormal deliveries, and all patients should be informed that treatment of melanoma is very essential because it can lead to infertility, according tothe FDA.

The American pharmaceutical company granted priority condition given to the experimental medicine, this medicine is a humanized monoclonal antibody that enhances the immune system’s ability to resist common melanoma. The American regulatory agency recommended the drug for this suggested Keytruda to use an expedited procedure, based on the tumor responds to healing and duration of response.

 

On the other hand the representatives of Merck announced that the medical corporation is going to apply for approval of the drug in the European Medicines Agency (European Medicines Agency, EMA) by the end of 2014.

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