A new drug for melanoma treatment is registered in the U.S.
Food and Drug Administration (FDA) registered an innovative drug called Pembrolizumab for the treatment of unresectable melanoma on an expedited basis. Drug developed by Merck & Co will be marketed under the trade name Keytruda.
In an official press release from the controlling agency it is noted that pembrolizumab became the first approved agent that blocks programmed cell death protein - 1 (PD1) and reduces the ability of the patient's immune system to recognize and destroy tumor cells.
The effectiveness of a new drug has been confirmed by clinical studies involving 173 patients who had not responded to previous therapy. All volunteers involved in the clinical trials were split into groups depending on clinical dosage of the Keytruda, which included 2 or 10 mg/kg. According to the results, receiving 2 mg /kg of the drug resulted in 24% decline of tumor for 50% of patients. Effect of treatment lasted at least 1,4-8,5 months. The outcome of the treatment was similar among patients taking the experimental drug in high doses.
As emphasized by the FDA staff, pembrolizumab became the sixth drug for melanoma treatment registered in the United States since 2011. Before it, marketing authorization was received by ipilimumab (2011), peginterferon alfa- 2b (2011), vemurafenib (2011), dabrafenib (2013) and trametinib (2013).
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