Sept. 21--A new drug used in a clinical trial at cancer centers including the John
Theurer Cancer Center at Hackensack University Medical Center appears so
promising in prolonging the life of melanoma patients that it has been granted
a priority review by the Food and Drug Administration.
Under this fast-track process, the FDA will make a decision on whether to
approve ipilimumab, by Bristol-Myers Squibb Co., in a six-month period -- by
Dec. 25 -- instead of the typical 10-month process.
The drug was used in a study involving 676 patients in 125 cancer centers
with stage III or IV metastatic melanoma who had been previously treated
unsuccessfully with other cancer drugs.
The study, published in the New England Journal of Medicine on Aug. 19,
shows about 23 percent of the patients given ipilimumab are alive two years
later, compared with 14 percent of those who did not receive the drug. Those
taking ipilimumab lived a median of about 10 months, compared with 6.4 months
for those who didn't take it.
"This shows us you can stimulate the immune system to fight cancer,
something that's always been a general belief, but with the exception of bone
marrow transplants, we haven't been able to do," said Dr. Andrew Pecora,
chairman and executive administrative director of the cancer center in
Hackensack. "It's really profound and opens a whole new avenue."
When melanoma strikes, a protein molecule, CTLA-4, is found on white
blood cells that suppresses the immune system from fighting the disease.
Ipilimumab blocks that protein so the immune system kicks in and fights the
cancer.
Whether the drug can be used for other cancers remains to be seen, Pecora
said.
"Cancer cells need to have certain proteins on the cells for the immune
system to recognize and fight," Pecora said. "Not all cancers have those
proteins. This drug isn't a home run and has a limited role. But just as they
figured out how to stimulate the immune system to fight polio, this is a
beginning."
Skin cancer is the most common form of cancer, with more than 1 million
people nationwide diagnosed with it annually. Health-care experts estimate one
in five Americans will get some type of it in their lifetime.
Of the different types, melanoma is the most deadly, with nearly 8,700
deaths attributed to it in 2009. Melanoma accounts for only 3 percent of all
skin cancers, but it is the cause of 80 percent of skin cancer deaths.
Melanoma that has metastasized -- spread from the skin to other parts of
the body -- has very few treatment options. Patients with late-stage melanoma
have a 15 percent survival rate.
The FDA grants priority reviews to drugs that offer major advances in
treatment when no other adequate therapy exists.
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