New drug gets accelerated approval
The U.S. Food and Drug Administration recently approved the drug pembrolizumab (Keytruda, Merck) for the use in treating advanced or unresectable melanoma in patients who have otherwise stopped responding to other drugs. The FDA granted accelerated approval to the drug.
Preliminary clinical evidence showed that Keytruda may offer improvement over other therapies, which fast-tracked the FDA’s approval. Clinical trials showed both its effectiveness and safety, and common side effects included fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia and diarrhea.
Keytruda is the sixth new melanoma treatment in a list of drugs approved since 2011, but it’s the first that blocks a cellular pathway known as PD-1, which restricts the immune system from attacking melanoma cells.
“This is the latest in a string of major breakthroughs in melanoma treatment that will galvanize the field of melanoma research and cancer treatment,” said Wendy Selig, president and CEO of the Melanoma Research Alliance.
To read the full article, click here: FDA approves new melanoma drug.
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