Just FDA

WEDNESDAY, Oct. 28, 2015 (HealthDay News) — A genetically engineered cold sore virus that “blows up” melanoma tumors has been approved by the U.S. Food and Drug Administration to help treat the deadly skin cancer.

Imlygic (talimogene laherparepvec), a first-of-its-kind therapy, showed promise against lesions in the skin and lymph nodes in an early trial, the FDA said Tuesday. However, the therapy did not improve overall survival and it did not work if the cancer had spread to other parts of the body, the agency noted.

“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “This approval provides patients and health care providers with a novel treatment for melanoma.”

The drug is injected directly into tumors, where it replicates inside cancer cells, causing them to rupture and die. Once the tumors have exploded, antibodies are released into the body that may trigger an immune response, the agency explained.

Treatment consists of a series of injections. After the first injection, a second dose is given three weeks later, followed by additional doses every two weeks for at least six months, until there are no remaining tumors to treat or other treatment is required, the FDA said in a news release.

The agency’s approval is based on a study of 436 patients with advanced melanoma that could not be surgically removed. Some patients received Imlygic and others received a different treatment.

Decreases in tumor size that lasted for a minimum of six months were seen in about 16 percent of patients who received Imlygic, compared with about 2 percent of those who received the other treatment, the findings showed.

Fatigue, chills, fever, nausea, flu-like symptoms and injection-site pain were the most common side effects reported among patients who received Imlygic.

Because Imlygic is a genetically modified herpes simplex 1 virus, it can also cause the kind of herpes infection that can lead to cold sores, so it shouldn’t be given to patients with weak immune systems or pregnant women, the FDA said.

Imlygic is manufactured by BioVex Inc., a subsidiary of Amgen Inc., based in Thousand Oaks, Calif.

The new treatment will not come cheap. A company statement said the six-month regimen will cost roughly $65,000. Amgen said it plans to make the treatment available to qualifying patients within a week.

Melanoma is the most dangerous type of skin cancer. This year, about 74,000 Americans will be diagnosed with the disease and nearly 10,000 will die from it, according to the U.S. National Cancer Institute.

More information

The American Cancer Society has more about melanoma.


What's Your Skin Cancer Risk? Check This Chart

Your chances of getting skin cancer are based on heredity—what you’re genetically predisposed toward—and your own tanning and burning history.

Answering these expert questions will give you a general idea of how vigilant you have to be. And if you are at high risk, find out how to check yourself for skin cancer at home or figure out if your doctor is checking you thoroughly during an exam.

What It Means That Jimmy Carter Is ‘Cancer

Former President Jimmy Carter announced that he is “cancer-free” after undergoing treatment for melanoma, which spread to his liver and his brain.

On Sunday, Carter, 91, told a church group in Georgia that his physicians could not find any cancer in his scans. “My most recent MRI brain scan did not reveal any signs of the original cancer spots nor any new ones,” he said in a statement. Carter says he will continue taking his regular 3-week immunotherapy treatments of the cancer drug pembrolizuma, which has shown promise in the treatment of melanoma.

So what exactly does it mean to be “cancer-free”?

Not seeing any cancer on imaging tests is promising, but a physician cannot be 100% certain that means a cancer will not return. Even with potent treatments there’s a chance that cancer cells could survive and grow over time. As the American Cancer Society notes, this is why doctors will rarely say a person is “cured.” Instead, they may say things like, “The cancer can’t be seen on the scan” or “I see no evidence of any cancer.” Usually by two or three months of treatment a doctor can look to see how a person’s cancer is responding.

Not all cancers will recur, and if cancer cells do survive treatment it could take years before they develop into identifiable disease.

According to the National Institutes of Health (NIH), if someone remains in complete remission—meaning all signs and symptoms of cancer are gone—for five or more years, some doctors may say a person has been “cured.” Still, cancer cells could remain in the body for many years after treatment.

Carter started his treatment in August, which consisted of a combination of radiation and a newer drug. The drug he was given, pembrolizumab (brand name Keytruda), is part of a rapidly growing class of drugs called immunotherapy, which uses the body’s immune system to fight the cancer. The drug received accelerated approval by the U.S. Food and Drug Administration (FDA) for certain conditions in 2014. In general, immunotherapy works in different ways from chemotherapy. Some treatments work by enhancing the immune system overall and other treatments specifically target cancer cells.

Using the immune system as a weapon against cancer makes a lot of sense. The job of the immune system is to identify “foreign” substances in the body and attack them. This is how our body kicks a cold or the flu. However, the immune system has a harder time identifying cancer cells as foreign, sometimes due to the fact that they don’t appear different enough from normal cells or the immune system isn’t powerful enough to take on the cancer. By using different strategies to bolster the immune system, researchers can get the immune system to better recognize cancer cells and launch a stronger attack. Some researchers are also looking into how to harness the knowledge gained from immunotherapy to develop cancer vaccines.

Immunotherapy has proven effective for melanoma, the type of cancer for which Carter received treatment. Reuters reports that about 30% of people treated with pembrolizumab experience significant tumor shrinkage. About 5% go into complete remission.

For now, President Carter will continue part of his treatment as he announced, and his status will likely be regularly monitored.

This story originally appeared on Time.com.

During Pregnancy, Skin Cancer May Be More Dangerous

WEDNESDAY, Jan. 20, 2016 (HealthDay News) — Women diagnosed with melanoma skin cancer during or just after pregnancy are at greater risk from the cancer than other women, a new study finds.

Pregnancy hormones may fuel the most deadly type of skin cancer, the researchers said.

“The rate of metastasis (cancer spread), recurrence and death in our findings were astounding—as the rates were measurably higher in women who were diagnosed with melanoma while pregnant, or within one year after delivery,” lead investigator Dr. Brian Gastman, a plastic surgeon and director of melanoma surgery at the Cleveland Clinic, said in a hospital news release.

However, the study was only designed to find a link between melanoma outcomes and pregnancy; it cannot show a cause-and-effect relationship.

The study looked at almost 500 women diagnosed with melanoma between 1988 and 2012. The women were aged 49 or younger. The researchers followed their health for two years or more.

The investigators found that women diagnosed with melanoma during pregnancy or within one year of giving birth were five times more likely to die of the cancer. They were also seven times more likely to have their cancer spread, and nine times more likely to have a recurrence of their cancer, compared with other women, the research revealed.

The study was published online Jan. 20 in the Journal of the American Academy of Dermatology.

Melanoma rates in the United States doubled between 1982 and 2011, the researchers said. These new study findings show that women younger than 50, especially those who are pregnant, need to be especially vigilant in monitoring themselves for signs of skin cancer, the researchers advised.

More information

The American Cancer Society has more about melanoma.


New Study Finds That Sunscreen Can Delay Melanoma in Mice

SUNDAY, April 17, 2016 (HealthDay News) — Applying 30 SPF sunscreen to mice before they were exposed to ultraviolet-B (UVB) radiation delayed the development of melanoma, researchers report.

The study results suggest that mice can be used to identify and develop new and more effective ways to prevent the most dangerous of skin cancers, the investigators said.

“Over the past 40 years, the melanoma incidence rate has consistently increased in the United States,” said lead investigator Christin Burd. She is an assistant professor in the department of molecular genetics and the department of molecular virology, immunology and medical genetics at Ohio State University’s cancer center.

“Sunscreens are known to prevent skin from burning when exposed to UV sunlight, which is a major risk factor for melanoma,” Burd said in a university news release.

“However, it has not been possible to test whether sunscreens prevent melanoma, because these are generally manufactured as cosmetics and tested in human volunteers or synthetic skin models,” she explained.

“We have developed a mouse model that allows us to test the ability of a sunscreen to not only prevent burns but also to prevent melanoma. This is a remarkable accomplishment. We hope that this model will lead to breakthroughs in melanoma prevention,” Burd concluded.

It’s important to note, however, that animal research often doesn’t produce similar results in humans.

The researchers were to present the results Sunday at the American Association for Cancer Research’s annual meeting, in New Orleans. The findings should be considered preliminary until published in a peer-reviewed medical journal.

According to the American Cancer Society, an estimated 76,000 Americans will be newly diagnosed with melanoma this year and nearly 10,000 will die from it.

More information

The U.S. Centers for Disease Control and Prevention has more on melanoma prevention.


'Sunscreen' Gene May Guard Against Skin Cancer

THURSDAY, May 19, 2016 (HealthDay News) — Scientists say they’ve identified a so-called “sunscreen” gene that may help protect against skin cancer.

They say the finding potentially could lead to new drugs to prevent the disease.

The investigators pinpointed the ultraviolet-resistant gene after analyzing data from 340 people with melanoma, the deadliest type of skin cancer, and conducting laboratory experiments.

“If we understand how this UV-resistant gene functions and the processes by which cells repair themselves after ultraviolet damage, then we could find targets for drugs to revert a misguided mechanism back to normal conditions,” said study senior author Chengyu Liang.

Liang is an associate professor of molecular microbiology and immunology at the University of Southern California Keck School of Medicine.

Cell damage from exposure to UV radiation causes more than 90 percent of melanoma skin cancers. Melanoma kills more than 10,000 people in the United States each year, according to the American Cancer Society.

“People who have the mutated UV-resistant gene or low levels of the UV-resistant gene may be at higher risk of melanoma or other skin cancers, especially if they go sunbathing or tanning frequently,” Liang said in a university news release.

“Our study suggests that the UV-resistant gene may serve as a biomarker for skin cancer prevention,” Liang added.

The investigators will conduct research with mice to learn more about how the UV-resistant gene functions.

“The UV-resistant gene may serve as a good target for drug development,” said study author Yongfei Yang, a research associate at Keck.

Perhaps one day a drug could stimulate the repair function of the UV-resistant gene to ensure swift and effective repair of UV-damaged skin cells, Yang said. “That would be a good treatment for people who are at high risk of developing skin cancer,” the researcher concluded.

The findings were published May 19 in the journal Molecular Cell.

More information

The American Academy of Family Physicians has more on skin cancer.


Genes Tied to Red Hair and Pale Skin May Raise Melanoma Risk

TUESDAY, July 12, 2016 (HealthDay News) — DNA that’s tied to red hair, fair skin and freckles may also be highly linked to a person’s genetic odds of skin cancer, new research suggests.

The study’s British authors estimate that having the gene is roughly equivalent to the person spending an extra 21 years in the sun.

“It has been known for a while that a person with red hair has an increased likelihood of developing skin cancer, but this is the first time that the gene [tied to red hair] has been proven to be associated with skin cancers with more mutations,” study co-lead author Dr. David Adams, of the Wellcome Trust Sanger Institute, said in an institute news release.

A skin cancer expert in the United States stressed that redheads can still prevent getting skin cancer. However, they may need a little extra help in determining their genetic risk.

“Identifying this subset of patients could [someday] help decrease the risk of melanoma and ultimately save lives,” said Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York City.

The genetics outlined in the study “make proper sun protection more important than ever, especially in this red-haired group,” Green said.

The gene mutation in question is called MC1R. As the researchers explained, this DNA affects the type of melanin pigment people produce in their skin.

People with red hair have two copies of a variant of this gene, which also results in pale skin that’s more prone to sunburns and freckles, Adams’ group said.

Carrying even one copy of this red hair-linked gene appears tied to a jump in the number of mutations linked to melanoma, the most serious form of skin cancer, the investigators found.

People with other hair hues aren’t off the hook, either. That’s because people who don’t have red hair can still carry these common variants, the researchers said. So they, too, should be careful about exposure to the sun’s harmful UV rays.

For the study, the researchers examined tumor DNA sequences collected from more than 400 people. There were 42 percent more mutations linked to sun damage in the tumors of those carrying the red hair gene variant than in those without that DNA, the findings showed.

All of this means that, for freckle-faced, red-haired people, skin cancer isn’t just about being more vulnerable to the sun’s harmful UV rays. Carrying the MC1R gene variant raises the number of mutations triggered by sun exposure, the researchers explained, but it also raises the level of non-sun-linked mutations within tumors.

“This important research explains why red-haired people have to be so careful about covering up in strong sun,” Dr. Julie Sharp, head of health and patient information at Cancer Research UK, said in the news release.

“It also underlines that it isn’t just people with red hair who need to protect themselves from too much sun,” she added. “People who tend to burn rather than tan, or who have fair skin, hair or eyes, or who have freckles or moles are also at higher risk,” Sharp explained.

“For all of us, the best way to protect skin when the sun is strong is to spend time in the shade between 11 a.m. and 3 p.m., and to cover up with a t-shirt, hat and sunglasses,” Sharp said. “And sunscreen helps protect the parts you can’t cover; use one with at least SPF15 and four or more stars, put on plenty and reapply regularly.”

Another melanoma expert agreed.

“The use of sunscreen is a modifying factor [in preventing skin cancer], and should be stressed,” said Dr. Ross Levy, chief of dermatology at Northern Westchester Hospital in Mount Kisco, N.Y.

The findings were published July 12 in Nature Communications.

More information

The American Cancer Society has more about skin cancer.


The Surprising Link Between White Wine and Melanoma

Alcohol has been linked to several different cancers, some more strongly than others. Now a study adds a new type of cancer to the list, and it’s an unexpected one: Brown University researchers say that drinking, even in moderate amounts, is associated with higher rates of melanoma—the deadliest form of skin cancer.

Their research revealed more interesting facts, as well. In the study, white wine had a bigger impact on risk than red wine, beer, or liquor. And compared with teetotalers, alcohol drinkers’ increased risk was greatest for body parts that normally aren’t exposed to the sun.

Some scientists have speculated that alcohol may make us more susceptible to sunburns, says co-author Eunyoung Cho, ScD, an associate professor of dermatology and epidemiology at the Warren Alpert Medical School of Brown University. But the new findings indicate there may be something else going on beneath the surface, she says.

About 3.6% of cancer cases worldwide are thought to be caused by alcohol, the authors note. “For some, like cancers of the digestive tract, the alcohol actually comes in contact with the tissue, so it’s easier to understand,” says Cho. “For others, like , we don’t really have a great explanation at this point why alcohol would be related.”

RELATED: 6 Things Your Dermatologist Wants You to Know About Skin Cancer

One theory, she says, is that a compound in alcohol called acetaldehyde can damage DNA, and prevent DNA repair, throughout the body. “It’s a well known carcinogen, so that could be a very general mechanism as to how alcohol relates to cancer at other sites,” she says.

There’s been little research on alcohol and skin cancer risk, however, and the studies that have been conducted have been inconclusive. They haven’t included much information about participants’ sun exposure, says Cho, which could affect the results.

So Cho and her colleagues collected data from three large studies involving 210,252 participants, all of whom provided information about their drinking habits, place of residence, and health history—including details about sunburns and tanning. Over an 18-year follow-up period, 1,374 people (less than 1% of all participants) were diagnosed with invasive melanoma

The results, published in the journal Cancer Epidemiology, Biomarkers & Prevention, showed that each drink per day was associated with a 14% higher risk of melanoma. (A standard drink was defined as 12.8 grams of pure alcohol, or about the amount found in one beer, glass of wine, or shot of hard liquor.)

And when the researchers looked at each beverage type individually, they found that one drink stood out: Each glass of white wine per day was associated with a 13% increased risk of melanoma, while other forms of alcohol did not affect risk in a statistically meaningful way.

RELATED: What Skin Cancer Looks Like

Some research has shown that wine has higher levels of acetaldehyde than beer or spirits, says Cho, while red wine’s greater antioxidant content may offset the risks of these compounds. 

But she won’t let other beverages off the hook just yet. “Other alcoholic beverages did show some positive correlation, but did not reach statistical significance,” she says. “For now, I would say that alcohol in general is related, and I would emphasize that white wine is particularly related.” 

Another surprise came when the researchers looked at melanoma rates on different body parts. People who drank 20 grams or more of alcohol per day (a little less than two drinks) were only 2% more likely than non-drinkers to be diagnosed with melanomas of the head, neck, arms, or legs.  But they were 73% more likely to be diagnosed with melanomas of the trunk—a body part often covered by clothing.

More research is needed to explain why this may be the case, says Cho. “There is a hypothesis that melanomas on different body sites may have different risk factors,” she says. “Based on these findings, I might guess that this type of cancer is less related to sun exposure and more related to a biological mechanism of alcohol damaging DNA or preventing DNA repair.”

RELATED: 6 Spots Your Doc Should Check for Skin Cancer

The study only included white people, so the results cannot be generalized to other races or ethnic groups. And because it was observational, it was not able to determine a cause-and-effect relationship between alcohol (and white wine specifically) and melanoma rates.

But the study did control for several factors, including the number of severe sunburns participants had ever had, their number of moles, and the average amount of ultraviolet radiation where they lived. These adjustments help strengthen the theory that alcohol really does play a role in melanoma development, Cho says—and not simply that people who drink regularly, or who prefer white wine, are more likely to spend hours by the pool or on the beach. (One thing they weren’t able to take into account, however, was sun-protection behaviors, such as using sunscreen.)  

“There are many risk factors for melanoma that you cannot change, like family history, hair color, and susceptibility to sunburn,” Cho says. “But drinking alcohol is something you can change, so it’s actually good to know that alcohol is related to melanoma as well as other cancers.”

The study’s findings support existing recommendations by the American Cancer Society to limit alcohol intake, she notes, but adds that moderate alcohol consumption has also been linked to a lower risk of heart disease. “People already know that alcohol consumption is related to increased risk for many cancers and we are just adding another one to that list,” she says. “For those who drink alcohol, its risks and benefits need to be considered individually—including the risk related to melanoma.”

This Woman’s Manicurist Spotted Melanoma Under Her Nail

UK manicurist Jean Skinner is being hailed as a hero after she spotted a sign of  on a client—and not on the woman’s hands, but actually under one of her nails.

The walk-in client had asked Skinner for a color that would cover up a dark, vertical stripe running down the center of her nail, Skinner explained in a Facebook post. But the nail artist immediately recognized the stripe as more than a beauty woe. “I did not want to frighten her, but I told her she needed to see the doctor immediately!” Skinner wrote.

RELATED: 6 Things Your Dermatologist Wants You to Know About Skin Cancer

Skinner’s hunch was correct: The client later called to say she had been diagnosed with that had already spread to her lymph nodes.

While there are plenty of nail changes that are totally harmless, this type of stripe or streak can be a sign of a kind of melanoma called acral lentiginous melanoma, or ALM. ALM is probably caused by genetic factors, since it usually occurs in places that don’t get much exposure to the sun, according to the Skin Cancer Foundation (SCF), such as under nails and on the palms of the hands. Because people tend to shrug off a little nail discoloration, ALM tends to be diagnosed later than other skin cancers, when it’s more likely to have spread to other parts of the body.

Melanoma is typically less common among Hispanic, Asian, and African American people, but when they do get melanoma, it’s more likely to be ALM, Cleveland Clinic dermatologist John Anthony, MD, told Health in a prior interview. In fact, musician Bob Marley died of ALM that spread from a dark spot under his toenail. He thought it was from a soccer injury, according to the SCF.

RELATED: Is It a Mole … or Skin Cancer?

Melanoma is still most likely to begin in a mole on the skin, but it’s important to know that this deadly skin cancer can be found anywhere on the body, including in your  and on your scalp. You can prevent some skin cancers by always using a broad spectrum sunscreen, but melanoma may also appear on places that you’d never sunburn, including inside your mouth and on the bottoms of your feet.

An experienced dermatologist will inspect all of these areas and more during an annual skin cancer screening, but you should also be on the lookout for any changes. In fact, the Skin Cancer Foundation recommends giving yourself a once-over from head to toe every month.

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“Please pay attention to abnormalities in your nail beds!” Skinner urged on Facebook. “Odd changes in your nails can very likely be nothing to worry about! But sometimes it is an indication of a very serious disease.” Next time you’re between polishes, take a closer look at your fingernails—and toenails too. Bring up anything that looks off with your dermatologist ASAP.