Health

FDA approves 'breakthrough' melanoma drug for limited use

Too much exposure to the sun may cause skin cancer.
Too much exposure to the sun may cause skin cancer.
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The Food And Drug Administration (FDA) gave limited approval Thursday to a new drug that’s showing positive results in the treatment of advanced melanoma. 

Called "Keytruda," the drug works by blocking a protein, called PD-1, that cloaks cancer cells and allows them to hide from the body's immune system.  

"This is a treatment that redirects the natural defenses that our body has and focuses it to attack the cancer," says the study's principal investigator, Dr. Antoni Ribas, a researcher at UCLA's Jonsson Comprehensive Cancer Center.

More than 600 people with advanced stages of melanoma, which is the most serious and deadly form of skin cancer, were treated with the new drug at UCLA and 11 other sites in the U.S., Europe and Australia.

Ribas says two-thirds of those who received the drug in the phase one trial are responding to the therapy, including a number with long-lasting tumor shrinkage.  

The FDA gave the drug "breakthrough therapy" status, which means for now its use is limited to those with the most advanced cases of melanoma.
 
But researchers say they’re hopeful the FDA will soon broaden its approval to patients with lesser stages of melanoma and some other types of cancer, once results from already-completed phase-two and phase-three studies come in.