FDA approves personalized Medicine drug for melanoma

TAMPA, Fla - Susan Steel's life has been all about numbers-- six years battling deadly metastatic melanoma, five clinical trials, a six to 15 percent chance of survival and hope nearing zero.

"I had no other options. That was it," Steele said.

Then she tried a new drug called Vemurafenib that shrunk her tumors by 70 percent in eight months.

"This is a real drug with major effects and major benefits to patients," said Dr. Jeffrey Weber, who took part in the trial.

 Moffitt Cancer Center being the only institution in Florida to do so.

"I was very impressed to see people who were arguably half way to death's door come in having lost 30 pound and then in weeks feel better with symptoms disappearing," he said.

Patients take four pills in the morning, four at night every day. The pink pill goes after a specific genetic mutation in a tumor that makes the cell grow out of control. The drug attaches itself to the mutant protein-- and simply kills the cancerous cell quickly.

"It clearly prolongs survival compared to any other treatment that we have, the so called standard chemotherapy that we have used in the past," Dr. Weber said. 

Like many treatments, there are side effects. Fatigue for one, and the other, the development of other cancers.

According to Weber, if that happens, "You cut them out and it happens in 20 to 25 percent of the patients but if you Аск the patients would they trade having to have a small surgery on their arm or leg or some exposed area to get rid of this exposed skin tumor for the response rate of 50 percent in prolonged survival that we've seen, they'll take the squamous cancer any day."

Melanoma is one of the most deadliest forms of cancer - usually patients live only 9 months - which is why this is such a big deal.

"We have some patients who have been on the drug well over a year a year and a half almost out to two years and their tumors have not returned," Dr. Weber said. 

The Food and Drug Administration approved both a genetic test and the drug at the same time this week.

Dr. Weber says physicians at Moffitt will be able to start writing prescriptions for the drug in about two weeks.

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