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FDA: More Options for Treating Dangerous Skin Cancers

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FDA approves more options for dangerous skin cancers Lev Dolgachov/PhotoSpin

Skin cancer is by far the most common cancer type in the United States and it’s becoming increasingly more so, according to the Food and Drug Administration, which in 2011 launched an aggressive effort to find more effective treatments.

The result is two new FDA-approved melanoma drugs and one treatment combination — Zelboraf (vemurafenib), Tafinlar (dabrafenib), and Mekinist (trametinib) in combination with Tafinlar — that have shown in clinical studies to shrink tumors in about half of patients.

A 50 percent effective rate may not sound like progress. But prior to 2011, the five standard chemotherapy drugs that were FDA-approved for treating melanoma were effective in less than 15 percent of patients.

“Most people who took those drugs didn’t get much benefit from them,” said Patricia Keegan M.D., an oncologist with FDA.

The emphasis for finding novel treatments have taken on importance for cancer researchers. New skin cancers are epidemic with significant increases reported in every U.S. state — up to 300 percent between 1994 and 2010 — according to a study published in the Archives of Dermatology.

There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and melanoma. Although melanoma is less common, accounting for less than 2 percent of skin cancer cases, it is by far the most aggressive — and deadly.

In recent years, melanoma skin cancers have risen dramatically across the country, with Colorado, Idaho, Kentucky, Missouri, Ohio, Oklahoma, Oregon, Tennessee, Utah, Vermont and West Virginia reporting the highest increases — 3.2-3.7 per 100,000 people, according to the latest U.S. Department of Health and Human Services surveillance report.

The National Cancer Institute estimates that more than 2 million new nonmelanoma and 76,100 melanoma skin cancers will be diagnosed in 2014.

Skin cancer becomes most dangerous when it invades normal tissue and spreads throughout the body. Less aggressive types cause fewer deaths but patients can face significant disfigurement.

Most of the damage to DNA in skin cells results from ultraviolet (UV) radiation found in sunlight and in the UV lights used in tanning beds and booths. But sun exposure doesn't explain skin cancers that develop on skin not ordinarily exposed to sunlight.

Researchers believe other factors may contribute to some skin cancer risk, such as being exposed to toxic substances or having a condition that weakens your immune system.

New Treatments for Skin Cancer Patients

Treatments to remove or destroy skin cancer depend on the type and stage of cancer.

The new FDA-approved treatments, Zelboraf, Tafinlar and Mekinist, are personalized medicines customized to individual patients at the molecular level to treat melanoma in patients whose tumors have the BRAF V600E gene mutation.

BRAF genes makes a human protein called B-Raf that directs cells to grow. When the BRAF gene is faulty, known as a “mutation”, the cells grow uncontrollably to form tumors.

“The science is targeting driver mutations and designing drugs that block them,” Keegan said. “It’s not always effective because tumors often find a back door or side route [to continue growing] when you shut down one path. So scientists are working on multiple therapies that work together to block various pathways.”

Patients who were given Zelboraf and another new melanoma drug, Yervoy (ipilimumab), lived longer than those who received traditional chemotherapy, Keegan says.

"Yervoy is a new class of immune therapy approved for melanoma that can't be removed with surgery and isn't limited to melanoma with certain gene mutations." The drug doesn’t actually attack the tumors, she said. Instead, it helps the body’s white blood cells recognize tumor cells as foreign and reject them. "Scientists have been trying to harness this ability for more than 100 years.”

Erivedge (vismodegib) is the first FDA-approved for treating metastatic basal cell carcinoma, a very serious cancer that effects a small fraction of the population, Keegan said. Doctors often can’t cut out certain tumors — maybe because they’re on the face, head, nose or eyelid — and patients end up with disfiguring lesions.

People with Gorlin syndrome — a rare form of skin cancer that can involve many parts of the body — are especially vulnerable because their cancer often returns or spreads.

Keegan said that Erivedge could give these patients options they never had before by shrinking their tumors and allowing them to control their lesions for months at a time.

“As oncologists, we’re still learning the best way to use Erivedge to control these really difficult lesions. The drug is effective for 30% to 40% of patients, but for them it’s a breakthrough because they have run out of options,” Keegan said.

Lynette Summerill is an award-winning writer and watersports junkie living in San Diego. In addition to writing about cancer for EmpowHER, her work has been seen in publications internationally.


Skin cancer patients have more treatment options. FDA Consumer Update. May 22, 1024

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2010 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2013.
Available at: www.cdc.gov/uscs

Nonmelanoma skin cancer jumps by approximately 300 percent. Skin cancer Foundation.

Skin cancer facts. American Cancer Society. May 2014.

Centers for Disease Control and Prevention. Skin Cancer Statistics by State. May 2014.

Skin Cancer. National Cancer Institutes. May 27, 2014.

Reviewed June 10, 2014
by Michele Blacksberg RN
Edited by Jody Smith

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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