The Skin Cancer Foundation Journal

MAY 2014

The 2012 edition of The Skin Cancer Foundation Journal features medically reviewed, reader-friendly articles such as tanning, the increasing incidence of skin cancer diagnoses among young women, & the prevalence of melanoma among white males over 50.

Issue link: https://skincancer.epubxp.com/i/319518

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F or the f rst time, the U.S. Food and Drug Administration (FDA) has approved a targeted combination therapy for advanced melanoma. Under its accelerated approval program, the FDA enabled the combined use of two drugs, dabrafenib (Taf nlar ® ) and trametinib (Mekinist ™ ); each had been approved individually in 2013 for inoperable or metastatic mela- noma patients with mutations in the BRAF V600E and BRAF V600K genes, found in more than half of all mela- nomas. The drugs work by "targeting" ( blocking) signals at two diff erent sites along the molecular pathway that pro- motes melanoma growth: dabrafenib blocks the defective BRAF protein and trametinib blocks the MEK protein, further downstream. The belief was that using the drugs in tandem would inhibit the pathway more completely and thus delay or prevent recurrence. In the study approval was based on, patients using dabrafenib alone devel- oped resistance within 5.6 months, while patients on the combined therapy saw their tumors shrink or dis- appear for an average of 10.5 months 1 Studies are under way to determine whether the combination therapy also extends patients' overall survival. FDA APPROVES FIRST TARGETED COMBINATION THERAPY FOR MELANOMA J ust two days of low-level sun exposure can begin to damage the skin at the molecular level, new research shows. Appearing in the December 2013 issue of JAMA Dermatology, the study from the University of Michigan Medical School found that minor amounts of exposure to ultraviolet A1 (UVA1) rays (340- 400 nm in the UV spectrum) triggered skin cells to manufacture molecules that break down collagen, the protein that keeps skin looking f rm and youthful. Although UVB rays are the major cause of sunburn, UVA rays com- prise the majority of UV light we are exposed to throughout the year, as well as the main wave- length used in tanning beds. They are known to be the major cause of UV-induced prema- ture skin aging (photoaging), and these new f ndings help explain why. Many sunscreens today of- fer protection against UVA rays – always look for sunscreens la- beled "broad spec- trum"– and the two best FDA-approved UVA1 f lters are zinc ox- ide and avobenzone. FIGHTING THE FDA'S GRIDLOCK ON NEW SUNSCREENS I n January 2002, the US Food and Drug Admin- istratrion (FDA) established its "Time and Extent Application" (TEA) process to expedite approval of new sunscreen ingredients. Since then, not a single ingredient has been approved. In fact, the last time the FDA approved a new sunscreen ingredient was 1999—15 years ago. Eight new sunscreen applica- tions have been pending since 2003, many of which off er vastly improved broad spectrum protection from the sun's harmful ultraviolet rays, and many of these ingredients have already been sold for years in Europe and other foreign markets. But this spring, headway has been made. A coalition called PASS (Public Access to SunScreens ) , of which The Skin Cancer Foundation is a founding member, helped introduce a bill into Congress that would push the FDA to speed up its currently derailed approval process. The bipartisan Sunscreen Innovation Act, currently in committee in both the House and Senate, would institute an eight-month deadline for the FDA to make decisions on new ingredients and streamline its current review process so that consumers would gain much faster access to the best available sunscreens. The PASS Coalition, comprised of public health organizations, dermatologists, sunscreen companies and concerned citizens, urges the public to contact their members of Congress to urge them to support the act. YES, A LITTLE SUN CAN HURT 11 References available on p. 95 Skin Cancer World News Roundup

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