Currents

Decision on Investigational Melanoma Agent Delayed

The FDA decision on GlaxoSmithKline’s investigational melanoma treatment trametinib has been extended to September 2013. GSK originally submitted a New Drug Application in August 2012, but the recent extension came after the company submitted additional manufacturing data for review. The proposed indication for trametinib is for treatment of unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.

Indoor Tanners Exhibit Psychiatric and Addictive Symptoms

Indoor tanning dependence among young women in particular has recently been associated with symptoms of anxiety and addiction. A new study examined 306 female university students between the ages of 18 and 25 and found that 46 percent of the sample reported a history of indoor tanning, with 25 percent being classified as tanning dependent. Multivariate logistic regression analyses showed that indoor tanning was significantly associated with symptoms of alcohol use disorders, generalized anxiety, and not having social anxiety. The authors noted that these findings suggest that young women with certain psychological problems may seek relief from their symptoms by indoor tanning. Moreover, the study concludes that indoor tanners may benefit from health behavior and other psychosocial interventions.

—Am J Health Promot. 2013; Apr 26

Combining Melanoma Therapies Could Pose Increased Safety Risks

The notion of combining the only two approved agents for the treatment of melanoma—vemurafenib (Zelboraf, Genentech) and ipilimumab (Yervoy, Bristol-Myers Squibb)— for potentially improved survival deserves more careful scrutiny, according to a recent editorial in The New England Journal of Medicine. Exploring the rationale to investigate combined therapy with the two agents, the authors conducted two small cohort studies aimed at evaluating safety as well as a potential administration schedule for further clinical development. In the second study, the authors observed elevations in aminotransferase levels in some patients within three weeks after starting ipilimumab. In addition, two patients (one in each cohort) had elevations of grade 2 or 3 in the total bilirubin level with concomitant grade 3 elevations in aminotransferase levels. The authors noted that all hepatic adverse events in the two cohorts were asymptomatic and reversible with either temporary discontinuation of the study drugs or administration of glucocorticoids. However, they also observed other toxic effects during the concomitant vemurafenib and ipilimumab phase, such as grade 2 temporal arteritis (in one patient) and grade 3 rash (in two patients), all in the first cohort. Upon closing the study to further patient accrual, the investigators observed that their findings reinforced the need for carefully conducted trials of new combination therapies, even when both agents have regulatory approval and distinct mechanisms of action.

— N Engl J Med. 2013; 368: 1365-6

New Skin Cancer Awareness Campaign: Outrun The Sun

“Outrun the Sun in May” is a new community outreach campaign running throughout Melanoma Awareness Month that encourages individuals to be both proactive— and active—in terms of skin cancer prevention. People worldwide are invited to register online and then either run or walk any day in May (from any location) in support of skin cancer education and melanoma research. Participants take a sun safety pledge and receive important sun safety and skin cancer prevention information. They may gather teams, running clubs, or participate in honor of someone undergoing melanoma treatment. Partnering with the campaign are the Dermatology Nurses’ Association, American College of Mohs Surgery, USA Track & Field, and the Road Runners Club of America. Registration information is available now at www.outrunthesun. org.