FDA Approves New Treatment for a Type of Late-Stage Skin Cancer

/PRNewswire/ --The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

Yervoy's safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed.

The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone.

Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects.

Yervoy is marketed by New York City-based Bristol-Myers Squibb.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

Lasers ID Deadly Skin Cancer Better than Doctors

High-resolution images from a laser-based tool developed at Duke University could help doctors better diagnose melanoma, the deadliest form of skin cancer.

The improved diagnoses could potentially save thousands of lives and millions of dollars in unnecessary healthcare costs each year.

The tool probes skin cells using two lasers to pump small amounts of energy, less than that of a laser pointer, into a suspicious mole. Scientists analyze the way the energy redistributes in the skin cells to pinpoint the microscopic locations of different skin pigments.

For the first time, scientists have the ability to identify substantial chemical differences between cancerous and healthy skin tissues, said Thomas Matthews, a Duke graduate student who helped develop the new two-laser microscopy technique.

The Duke team imaged 42 skin slices with the new tool. The images show that melanomas tend to have more eumelanin, a kind of skin pigment, than healthy tissue. Using the amount of eumelanin as a diagnostic criterion, the team used the tool to correctly identify all eleven melanoma samples in the study. The results appear in the Feb. 23 Science Translational Medicine.

The technique will be further tested using thousands of archived skin slices. Studying old samples will verify whether the new technique can identify changes in moles that eventually did become cancerous.

Even if the technique proves, on a large scale, to be 50 percent more accurate than a biopsy, it would prevent about 100,000 false melanoma diagnoses, said Warren S. Warren, director of Duke’s Center for Molecular and Biomolecular Imaging and a chemistry professor. Warren oversaw the development of the new melanoma diagnostic tool.

cancertissueWarren's group has succeeded in using the laser pump method to locate two different types of skin pigments in skin tissue, which may better identify developing melanoma, said James Grichnik, a dermatologist at the University of Miami who was not involved in the study.

The work is limited to fixed tissue on slides, but holds promise for diagnosing melanoma prior to biopsy, and the increased diagnostic accuracy, without unnecessary biopsies, is where the new tool could have cost-saving potential, he said.

Melanoma is the fifth-most common cancer for males and sixth-most common for females. In 2010, U.S. doctors diagnosed nearly 115,000 new cases of the disease, with nearly 8,700 resulting in death. The cancer is also one of the few where the death rate is increasing.

Doctors typically use a light and a magnifying glass or tissue biopsy, where a pathologist removes suspicious skin cells and looks at them under a microscope, to spot signs of disease. But using a lens and a light is a “17th century” technique that is only 85 percent accurate, at best, and tissue biopsy is not much more reliable, Warren said.

In 14 percent of biopsy diagnoses, pathologists would disagree on whether or not the sampled cells were cancerous, according to a 2010 study published in the Journal of American Academy of Dermatology. The statistic implies that two pathologists would have opposing diagnoses on 214,000 to 643,000 melanoma cases each year, Warren said.

When studying biopsied tissue, doctors typically follow the “when in doubt, cut it out” philosophy. If they are not sure about the health of the skin tissue, doctors remove additional skin around the diseased cells. The first and second tissue biopsies can cost thousands of dollars. If the melanoma is thought have spread, patients may then have lymph nodes in their arms removed or undergo chemotherapy, which dramatically adds to treatment costs.

But not all of the extra treatment is necessary because not all of the biopsied tissues are actually cancerous. Doctors need a more accurate way to diagnose melanoma, Warren said.

In 2009, he received a $1 million Challenge Grant from the National Institutes of Health, which was part of the American Recovery and Reinvestment Act of 2009, to develop the imaging tool.

The highly specialized lasers are currently commercially available and would only need to be added to the microscopes pathologists already use to diagnose melanomas. The cost for the added instrumentation is about $100,000, which may sound like a lot of money. But if each false positive melanoma diagnosis costs thousands of dollars, having such an instrument available for questionable cases could considerably reduce health care costs overall, Warren said.

He added that suspicious moles would still have to be removed from a patient and then imaged to detect cancer.

Matthews is working on imaging skin cancers grafted on to mice to see if the tool could become a device dermatologists could use to scan a mole without removing it. A device like that would be much more expensive and would not be ready for a few years, Warren said. However, pathologists could begin using the lasers to study biopsied tissue now.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

FDA Approves Teflaro for Bacterial Infections

The U.S. Food and Drug Administration today (October 29) approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.

CABP is a bacterial infection that develops in the lungs of patients who are exposed to the bacteria in their normal environment, and not in the hospital. ABSSSI is a bacterial infection of skin and skin structures that requires antibiotic treatment and may require surgical treatment.

MRSA is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin, and amoxicillin. In the community, most MRSA infections are skin infections. Severe or potentially life-threatening MRSA infections occur most frequently among patients in contact with health care settings, according to the Centers for Disease Control and Prevention.

“These are serious and potentially life-threatening infections for which new treatment options are needed,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. “FDA is committed to facilitating new antibiotic drug development.”

The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI). In the CABP trials, the comparator antibacterial treatment was Rocephin (ceftriaxone) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin (vancomycin) plus Azactam (aztreonam).

In the CABP trials, 1,231 adult patients received Teflaro or Rocephin. Clinical response based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Teflaro was comparable to Rocephin.

In the ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam. Clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint. In both trials, Teflaro was comparable to Vancocin plus Azactam.

The most commonly reported side effects in patients treated with Teflaro included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.

Teflaro is marketed by New York City-based Forest Laboratories.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

New Study Evaluates Effectiveness of Vitamins for the Treatment of Sun-Damaged Skin

/PRNewswire/ -- While everyone knows that getting an adequate daily dose of vitamins and minerals is important in maintaining one's overall health, many question whether or not the vitamins touted in skin care products work in reducing the signs of sun-damaged skin. Now, a new study reviews the currently published scientific literature to determine what evidence exists to support the use of vitamins in skin care products to slow or reverse the effects of sun damage.

In the report entitled, "Vitamins and photoaging: Do scientific data support their use?", published online in the Journal of the American Academy of Dermatology, dermatologist Jenny Kim, M.D., Ph.D., FAAD, associate professor in the division of dermatology, department of medicine, at the University of California, Los Angeles (UCLA), David Geffen School of Medicine in Los Angeles, presented results of a study that may support the use of certain vitamins in oral or topical formulations.

"It is well documented that ultraviolet (UV) radiation contributes to premature skin aging through the process of photoaging, and there is increasing evidence that the antioxidant properties of vitamins may contribute to the prevention and treatment of photoaging," said Dr. Kim. "In fact, numerous companies developing cosmeceuticals base their effectiveness claims on the fact that their formulations contain vitamins proven in laboratories to modify cellular processes thought to contribute to the appearance of photoaged skin. As dermatologists, we can help our patients navigate this maze of marketing claims by sharing scientific data on the known efficacy of vitamins in skin care products."

Based on a comprehensive review of the available published data on the role of vitamins in skin care products, Dr. Kim and her colleagues, Jamie Zussman, M.D., FAAD, and Jennifer Ahdout, M.D., found there is evidence to support the potential role of vitamins A, C, E, and B3 in modifying the photoaging process.

"While it's evident that these vitamins can play a role in fighting sun damage, the question still remains whether these properties are effective when delivered in skin care products," notes Dr Kim.

Vitamin A: Effective in treating a variety of skin conditions

The two most common forms of vitamin A studied for their role in protecting the skin from UV-induced damage are retinols and carotenoids. Retinol is found in foods such as liver, milk and eggs, and is the most biologically active form of the vitamin. Carotenoids are found in many fruits and vegetables, and have strong antioxidant capabilities.

While carotenoids are not shown to be beneficial in the treatment of photoaging, research suggests that they may play a role in photoprotection by preventing UV-induced collagen breakdown.

"Although the evidence available at this time is not strong enough to offer definitive support for the use of dietary carotenoids for photoprotection, a role for carotenoids as a supplement to photoprotective agents should not be discounted yet," said Dr. Kim. "We hope to see larger-scale clinical trials conducted to further explore the photoprotective effects of carotenoids."

Unlike carotenoids, there is vast evidence supporting the role of topical retinoids (the class of substances formed by retinol and its natural and synthetic derivatives) in treating photoaged skin. For example, prescription retinoid formulations have the most scientific data to support their use in this area.

Dr. Kim noted that both tretinoin cream (0.025% and 0.05%) and tazarotene cream (0.1%) are already FDA-approved for the treatment of fine wrinkles, skin roughness and mottled hyperpigmentation caused by aging and sun exposure. In addition, she added that studies of other retinoids have shown that a once-daily application of 0.1% isotretinoin cream for 36 weeks was effective in reducing fine wrinkles.

Retinoids also are found in over-the-counter cosmeceuticals, but there is less clinical evidence supporting their effectiveness in improving photoaged skin. "An important point to remember with retinoids is that we cannot assume that all retinoids are equal in their ability to fight photoaging," said Dr. Kim. "In over-the-counter products, retinol appears to be the most effective retinoid based on clinical studies completed to date. However, patients should consult their dermatologist before using any topical retinoid, as side effects can occur when used with other topical products. When properly instructed by a dermatologist, most patients can tolerate topical retinoids and benefit from their effect."

Dr. Kim added that unlike topical retinoids, there is minimal evidence supporting the use of oral retinoids in the treatment of photoaging.

Vitamin C: Possible skin care product value

Vitamin C, a water-soluble vitamin also known as ascorbic acid that is found in citrus fruits and dark green leafy vegetables, plays an essential role in the production of collagen and elastin. Because of its antioxidant properties, vitamin C may reverse the negative effects of UV radiation in the skin, but there are few clinically controlled studies to confirm this theory.

"An animal study examining the role of vitamin C in reversing sun damage found that when 5% ascorbate was applied two hours before UVB and UVA exposure, UVB-induced skin wrinkling was reduced," said Dr. Kim. "Some of the human clinical trials have shown similar favorable results when applying a daily dose of L-ascorbic acid treatment, but all of these studies involved small sample sizes."

In addition, Dr. Kim pointed out that one concern of adding vitamin C to cosmeceuticals is that vitamin C is unstable when used in formulations, and it is not known how much, if any, intact molecule remains when applied to the skin.

"This problem has been partially overcome by chemically modifying ascorbic acid," said Dr. Kim. "However, for the body to use the supplied ascorbic acid, it must convert it to L-ascorbic acid, and many of the stabilized, commercially available forms have not been examined to determine whether this conversion is possible. For that reason, the average consumer will not be able to determine if a cosmeceutical containing vitamin C will be effective."

Vitamin E: A primary antioxidant

Vitamin E, or tocopherol, is a fat-soluble vitamin, and its synthetic form is found in many over-the-counter products. Working as an antioxidant, vitamin E protects cell membranes and is thought to play an important role in skin aging because of its antioxidant properties. While topical vitamin E is available in a variety of products, there is no data which support claims that it improves skin wrinkling, discoloration and texture.

"Topical vitamin E has been studied in humans, as in mice, more as a protectant to be used before sun exposure than as an agent to be included in cosmeceuticals to reduce the signs of skin aging," said Dr. Kim. "Through research we have learned that UV exposure significantly decreases levels of cutaneous vitamin E, and vitamin C should be included in any formulation containing vitamin E because of the important role it plays in maintaining active vitamin E levels."

Research also has explored combining vitamins E and C as an oral supplement to provide sun protection. Multiple studies suggest that this combination therapy is beneficial for photoprotection. However, Dr. Kim noted that overzealous oral vitamin E supplements may be harmful, and two new studies also suggest that a high intake of vitamin E may be associated with an increased risk of basal cell carcinoma.

Vitamin B3: A possible treatment for photoaging

The B vitamins consist of eight different water-soluble vitamins that are found in a variety of foods. Vitamin B3 has been shown to reduce blood cholesterol and atherosclerosis (a condition in which fatty materials collect along artery walls), but now new insights are examining its role as an effective treatment for several skin conditions - from acne to photoaging.

Specifically, Dr. Kim noted that vitamin B3 has been found to increase collagen production in in vitro studies and to reduce skin hyperpigmentation (dark spots) in clinical studies.

"There has been one clinical trial conducted in Caucasian women in which 50 women applied 5% niacinamide (topical vitamin B3) to one side of their faces twice per day for 12 weeks, and these women experienced significant reductions in the appearance of hyperpigmented spots, redness, wrinkles, and yellowing, as well as improved skin elasticity," said Dr. Kim. "While initial studies show promise that topical vitamin B3 may prevent UV-induced skin aging, larger clinical trials are needed to confirm its role as a definitive treatment of photoaging."

Bottom Line: Maintain healthy lifestyle, healthy diet, practice sun protection

Dr. Kim added that it is important for everyone to get an adequate daily supply of vitamins to maintain a healthy lifestyle, and any insufficiencies may negatively impact the skin's overall appearance.

"Research has shown a potential role for various vitamins in reducing the damaging effects of sun exposure on the skin. Whether topical or oral formulations containing these vitamins have a protective effect is uncertain. Given the number, type and variability of preparations available, consumers should understand from our study that skin care products with vitamins may not provide clinically meaningful improvement," said Dr. Kim. "What is known is that proper sun protection is key to the prevention of photoaging and should be top of mind at all times."

For more information on improving the appearance of your skin, go to the "AgingSkinNet" section of www.SkinCarePhysicians.com, a Web site developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.

Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Approves New Drug to Treat Psoriasis

The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

"This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance," said Julie Beitz, M.D., director, Office of Drug Evaluation III, in the FDA's Center for Drug Evaluation and Research.

Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body's own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

Three studies of 2,266 patients evaluated the biologic's safety and effectiveness.

Since Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.

The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

Stelara is manufactured by Centocor Ortho Biotech Inc. of Horsham, Pa., a wholly-owned subsidiary of Johnson & Johnson of New Brunswick, N.J.

----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
GeorgiaFront Page