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Japan Approves World's First PD-1 Drug, Nivolumab

Japan Approves World's First PD-1 Drug, Nivolumab | Melanoma Dispatch | Scoop.it

"Ono Pharmaceutical Co has become the first company in the world to get an approval for a PD-1 checkpoint inhibitor, as regulators in Japan gave the green light to nivolumab, developed with Bristol-Myers Squibb, as a treatment for melanoma.

"The drug will be marketed as Opdivo for unresectable melanoma although Ono noted that because of the very limited number of patients treated with nivolumab in Japanese clinical trials, the firm is required to perform a 'post-marketing use-results survey covering all cases until data on a certain minimum number of patients have been accumulated'."


Editor's note: The drug nivolumab is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. Nivolumab is a specific kind of immunotherapy drug known as a "PD-1 checkpoint inhibitor," since it works by releasing a protein "brake" on the immune system called PD-1. Researchers testing the drug in volunteer patients have found promising results, and Japan has now given the world's first approval to nivolumab, permitting doctors across the country to prescribe it to people with unresectable melanoma.

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PharmaTimes  |  Jul 7, 2014

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Study Offers Evidence that Sunscreen Use in Childhood Prevents Melanoma in Adults

Study Offers Evidence that Sunscreen Use in Childhood Prevents Melanoma in Adults | Melanoma Dispatch | Scoop.it

"Research conducted at the Texas Biomedical Research Institute, published in the latest issue of the scientific journal Pigment Cell and Melanoma, has established unequivocally in a natural animal model that the incidence of malignant melanoma in adulthood can be dramatically reduced by the consistent use of sunscreen in infancy and childhood.


"According to senior author John L. VandeBerg, Ph.D., the research was driven by the fact that, despite the increasing use of sunscreen in recent decades, the incidence of malignant melanoma, the most aggressive form of skin cancer, continues to increase dramatically. The American Cancer Society estimates that more than 75,000 new cases of melanoma will be diagnosed in the U.S. this year."

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Medical Xpress  |  Jun 19, 2014

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Adjuvant Ipilimumab Improved RFS in High-Risk, Stage III Melanoma

Adjuvant Ipilimumab Improved RFS in High-Risk, Stage III Melanoma | Melanoma Dispatch | Scoop.it

"Adjuvant ipilimumab significantly improved RFS compared with placebo among patients with resected stage III melanoma who were at high risk for recurrence, according to the final analysis of a phase 3 study presented at the ASCO Annual Meeting.


“ 'Although there are approved adjuvant therapies, they are still to be improved, and this is clearly an unmet need,' researcher Alexander Eggermont, MD, PhD, director general of the Gustave Roussy Cancer Campus Grand Paris in France, said during a press conference. 'Ipilimumab is the first drug approved for metastatic melanoma, based on a proven impact on OS. This is the first trial ever with a drug that had an improvement in OS in metastatic melanoma.' "


Editor's note: Patients with advanced melanoma who have their tumors removed by surgery ("resected") can be at high risk for recurrence of their cancer. In a clinical trial with volunteer patients, researchers are testing an "adjuvant" treatment meant to prevent recurrence. All patients had resected stage III melanoma. It was found that patients who took the drug ipilimumab (Yervoy) after resection had a significantly greater amount of time pass before recurrence than patients who took a placebo. Further follow-up of the patients will reveal effects on overall survival.

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Healio  |  Jun 10, 2014

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ASCO: Targeting PD-1 Works in Advanced Melanoma

ASCO: Targeting PD-1 Works in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"Two studies indicate that using investigative immunotherapy drugs improves survival and response in patients with metastatic melanoma, researchers said here.


"In one study, the agent pembrolizumab (MK-3475) which targets the programmed death (PD-1) pathway produced a 1-year 69% survival rate, said Antoni Ribas, MD, PhD, professor of medicine at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles.


"In a second study reported in a press conference at the annual meeting of the American Society of Clinical Oncology, Mario Sznol, MD, professor of medicine at the Yale Cancer Center, demonstrated that a combination of the investigative PD-1 inhibitor nivolumab in combination with another targeted agent ipilimumab (Yervoy) produced a 1-year survival rate of 85% and 2-year survival rate of 79% for advanced melanoma patients."


Editor's note: Immunotherapy drugs boost a patient's own immune system to fight cancer. Promising research into new immunotherapy drugs for melanoma was recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Two treatments that received special attention were MK-3475 (aka pembrolizumab) and a combination of the drugs ipilimumab (Yervoy) and nivolumab.

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MedPage Today  |  Jun 5, 2014

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Incyte : Announces Preliminary Results of a Phase I/II Study of Combination Immunotherapy in Patients with Melanoma

"Incyte Corporation (Nasdaq: INCY) today announced that preliminary results from an ongoing Phase I/II study of INCB24360, its oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, combined with ipilimumab in patients with unresectable or metastatic melanoma were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 to June 3, 2014, in Chicago. The poster reported initial findings showing that the combination was generally well tolerated and produced evidence of clinical response."

Editor's note: This article discusses a new treatment for melanoma that combines a drug called INCB24360 with the drug ipilimumab (Yervoy). Both drugs are immunotherapies, meaning they boost a patient's own immune system to fight cancer. A clinical trial testing the combo in volunteer patients found promising preliminary results.
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4-traders  |  Jun 2, 2014

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Immunotherapy Shows Promise Against Melanoma

Immunotherapy Shows Promise Against Melanoma | Melanoma Dispatch | Scoop.it

"By unleashing the immune system to attack skin cancer, researchers have made important strides against melanoma, according to the results of three clinical trials released Monday.


"The first study presented at the American Society of Clinical Oncology annual meeting showed patients given a drug called Yervoy (ipilimumab), made by Bristol Myers-Squibb, saw a 25 percent reduced risk of the cancer coming back when compared to a placebo."


Editor's note: Immunotherapy treatments, which boost a patient's own immune system to fight cancer, were a big topic this past weekend at the American Society of Clinical Oncology (ASCO) Annual Meeting. This article provides an overview of some new findings in immunotherapy for melanoma.

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Medical Xpress  |  Jun 2, 2014

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New Therapies Harness Power of the Immune System Against Cancer

New Therapies Harness Power of the Immune System Against Cancer | Melanoma Dispatch | Scoop.it

"New research on innovative immunotherapies for advanced or high-risk melanoma and cervical cancer were presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO). These treatments – used alone or in combination – fight cancer by activating and amplifying the body's immune response to the disease.


"The new studies find high activity with investigative drugs for advanced melanoma, and show for the first time that ipilimumab, a treatment already approved for advanced melanoma, can substantially decrease the risk of melanoma recurrence in certain patients with earlier-stage disease. In addition, another small trial reports that a one-time, personalized immunotherapy treatment induces complete and long-lasting remissions in a small number of women with advanced cervical cancer – a disease with little to no effective treatment options."


Editor's note: Immunotherapies are treatments that boost a patient's own immune system to fight cancer. Learn more.

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Medical Xpress  |  Jun 2, 2014

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NeoStem Presents Data at ASCO Annual Meeting

"NeoStem, Inc., a leader in the emerging cellular therapy industry, today announced results of a pooled analysis indicating that Melapuldencel-T, an investigational patient-specific immunotherapy for metastatic melanoma, may increase survival rates significantly for patients at the most advanced stages of the disease. The findings will be presented on Sunday, June 1 in a poster by Robert O. Dillman, MD, study author and Vice-President, NeoStem Oncology, at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago."


Editor's note: This is a press release from a company that manufactures an immunotherapy treatment for melanoma. The treatment, called Melapuldencel-T, is meant to boost a patient's own immune system to fight cancer. A recent study testing Melapuldencel-T in patients found promising results for the treatment.

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NeoStem  |  May 29, 2014

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Indoor Tanning, Even Without Burning, Increases the Risk of Melanoma

Indoor Tanning, Even Without Burning, Increases the Risk of Melanoma | Melanoma Dispatch | Scoop.it

"People sometimes use indoor tanning in the belief that this will prevent burns when they tan outdoors. However, indoor tanning raises the risk of developing melanoma even if a person has never had burns from either indoor or outdoor tanning, according to a study published May 29 in the JNCI: Journal of the National Cancer Institute.


"To test the hypothesis that indoor tanning without burns prevents sunburn and subsequent skin cancer, researchers at the Masonic Cancer Center, Department of Dermatology, and Division of Epidemiology and Community Health, University of Minnesota, Minneapolis used data from a case-control study on indoor tanning and the risk of melanoma. The researchers had detailed information on indoor tanning and sun exposure for the study participants and excluded those who experienced a burn while tanning indoors."

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Medical Xpress  |  May 28, 2014

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Scientists Find New Way to Combat Drug Resistance in Skin Cancer

Scientists Find New Way to Combat Drug Resistance in Skin Cancer | Melanoma Dispatch | Scoop.it

"Rapid resistance to vemurafenib – a treatment for a type of advanced melanoma, the deadliest form of skin cancer – could be prevented by blocking a druggable family of proteins, according to research published in Nature Communications today.


"Scientists at the Cancer Research UK Manchester Institute, based at the University of Manchester, have revealed the MLK family of four enzymes 'undoes' the tumour-shrinking effects of vemurafenib."


Editor's note: This story describes a potential new way to treat melanoma that has become resistant to vemurafenib. While promising, the research is still in preliminary stages, so new treatments are not yet available for patients.

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Medical Xpress  |  May 22, 2014

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Melanoma Detection Enhanced with Blood Biomarkers

Melanoma Detection Enhanced with Blood Biomarkers | Melanoma Dispatch | Scoop.it

"The need for invasive skin biopsies could be reduced extensively with Edith Cowan University researchers working on ways to detect melanoma in early stages, using a blood test in conjunction with visual scans.


"A $450,000 National Health and Medical Research Council development grant has enabled them to expand on a 2012 preliminary investigation of 40 people that identified eight blood biomarkers that indicated the early presence of melanoma tumour.


"ECU School of Medical Sciences Professor Mel Ziman conducted the original investigation and is working with PhD student Pauline Zaenker and postdoctoral research fellow Dr Elin Gray on the latest study."

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Medical Xpress  |  May 13, 2014

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Blue Nevi Acquired in Older Men, Lacked Association with Melanoma

Blue Nevi Acquired in Older Men, Lacked Association with Melanoma | Melanoma Dispatch | Scoop.it

Blue nevi commonly occurred in older men and usually were not associated with melanoma, according to recent study results.


" 'Our findings support the concept that benign [blue nevi] are not uncommonly acquired in older age individuals and that they may be safely clinically followed in the absence of concerning clinical and/or dermoscopic features,' the researchers said."

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Healio  |  May 7, 2014

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Binimetinib Continues To Advance In Clinical Development

Binimetinib Continues To Advance In Clinical Development | Melanoma Dispatch | Scoop.it

"Three Phase 3 trials with binimetinib continue to enroll in advanced cancer patients:  NRAS-mutant melanoma (NEMO / NCT01763164), low-grade serous ovarian cancer (MILO / NCT01849874) and BRAF-mutant melanoma (COLUMBUS / NCT01909453).  NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing from the NRAS-mutant melanoma study estimated to be in 2015."


Editor's note: This is a press release from a company that is testing a new potential treatment for melanoma called binimetinib, or "MEK162." The drug is being tested in clinical trials (learn more about clinical trials). One of the trials is enrolling melanoma patients whose tumors have mutations in the NRAS gene, as detected by molecular testing. Another is enrolling patients with BRAF mutations.

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Array Biopharma  |  Apr 23, 2014

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UPDATE 1-Bristol Immunotherapy Prolongs Survival in Melanoma Trial

"A late-stage trial testing Bristol-Myers Squibb Co's cancer immunotherapy nivolumab in advanced melanoma patients was halted early after it was determined that the drug was likely to prolong survival, the company said on Tuesday..."


"The 418-patient Phase III study, called CheckMate -066, was testing nivolumab as an initial, or first line, therapy for patients with advanced melanoma, the deadliest form of skin cancer."


Editor's note: In a clinical trial with volunteer melanoma patients, researchers have been testing a new drug called nivolumab to see if it is a good first treatment for people with advanced melanoma. Nivolumab is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. In the clinical trial, some of the patients were being treated with nivolumab, and some with a standard chemotherapy drug called dacarbazine. Nivolumab showed so much better results than dacarbazine that the trial was ended early, and the patients who had been taking dacarbazine were switched to nivolumab.

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Reuters  |  Jun 24, 2014

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Acral Melanoma Tumors May Require More Aggressive Surgical Treatment

Acral Melanoma Tumors May Require More Aggressive Surgical Treatment | Melanoma Dispatch | Scoop.it

"Acral melanoma was found to have higher recurrence and lower survival rates than other types of melanoma and may require more aggressive surgical intervention, according to researchers.


"The researchers selected patients from a prospectively enrolled cohort of primary melanoma patients at NYU Langone Medical Center; 61 patients with acral melanoma and 183 patients with non-acral melanoma were included. Median follow-up was 33 months in the acral melanoma cohort and 58 months in the non-acral melanoma cohort."

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Healio  |  Jun 11, 2014

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Sex, Age, Race Affected SCC Risk Among Melanoma Patients

Sex, Age, Race Affected SCC Risk Among Melanoma Patients | Melanoma Dispatch | Scoop.it

"Approximately 12% of patients with melanoma developed subsequent squamous cell carcinoma, and the occurrence was more common among men, whites, older patients and those with a history of nonmelanoma skin cancer, according to recent study results.


"Researchers studied 6,378 Kaiser Permanente Northern California (KPNC) members (mean age, 60.9 years; 56.6% men) who received a melanoma diagnosis between 2000 and 2005. The patients were followed through 2009, with 1,462 meeting criteria for squamous cell carcinoma (SCC) pathology review. There were 766 patients with defined SCC (69.7% men)."

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Healio  |  Jun 2, 2014

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Ipilimumab Nivolumab Combination Demonstrated Encouraging Activity in Advanced Melanoma

Ipilimumab Nivolumab Combination Demonstrated Encouraging Activity in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"The combination of the immunotherapy agents ipilimumab and nivolumab induced extensive and durable tumor shrinkage in patients with advanced melanoma, according to long-term study results presented at the ASCO Annual Meeting.

“ 'These are two distinct immune checkpoint inhibitors, so it makes sense to combine them together,' researcher Mario Sznol, MD, a professor of medical oncology at Yale School of Medicine, said during a press conference. 'They both produce very significant clinical activity as monotherapy in advanced melanoma.' ”

Editor's note: Immunotherapy treatments boost a patient's own immune system to fight cancer. A new immunotherapy treatment combines two individual immunotherapy drugs: ipilimumab (Yervoy) and nivolumab. In a clinical trial to test the combo in volunteer patients with advanced melanoma, the treatment was found to provide promising survival results. Further studies are needed to see just how well the treatment might work.

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Healio  |  Jun 4, 2012

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MK3475 Induced High Rates of Durable Responses in Advanced Melanoma

MK3475 Induced High Rates of Durable Responses in Advanced Melanoma | Melanoma Dispatch | Scoop.it

"A majority of patients with advanced melanoma who had and had not received previous ipilimumab demonstrated durable responses with the PD-1 targeted antibody MK-3475, according to study results presented at the ASCO Annual Meeting.


“ 'This is the largest phase 1 clinical trial ever conducted in this disease, and together with a lung cancer cohort, this is the largest phase 1 trial ever done in oncology,' study investigator Antoni Ribas, MD, PhD, professor of medicine at the David Geffen School of Medicine at the University of California in Los Angeles, said during a press conference. 'These are early data, but they tell us we are on to something really important.' ”


Editor's note: The cancer drug MK-3475 is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. This story describes a clinical trial that tested MK-3475 on volunteer patients with advanced melanoma, and found good results for a majority of the patients. Some of the patients had previously been treated with the drug ipilimumab (Yervoy) and some had not; both kinds of patients benefited from MK-3475 in the trial.

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Healio  |  Jun 3, 2014

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Long-Term Results Encouraging for Combination Immunotherapy for Advanced Melanoma

Long-Term Results Encouraging for Combination Immunotherapy for Advanced Melanoma | Melanoma Dispatch | Scoop.it

"The first long-term follow-up results from a phase 1b immunotherapy trial combining drugs for advanced melanoma patients has shown encouraging results—long-lasting with high survival rates—researchers report. First author Mario Sznol, M.D., professor of medical oncology at Yale Cancer Center, is presenting the updated data at the 2014 annual conference of the American Society of Clinical Oncology (ASCO) in Chicago.


"Sznol, clinical research leader of the melanoma research program at Yale Cancer Center, was the senior author on the original study of combination immunotherapy that was first published in the New England Journal of Medicine and presented at ASCO in 2013. Jedd Wolchok, M.D., of Memorial Sloan Kettering Cancer Center was first author of the earlier study, and senior author of this updated research."


Editor's note: Immunotherapy treatments boost a patient's own immune system to fight cancer. This story describes a promising treatment that combines two immunotherapy drugs: nivolumab and ipilimumab (Yervoy).

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Medical Xpress  |  Jun 2, 2014

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Combination Dabrafenib/Trametinib Increased PFS in BRAF-Positive Melanoma

Combination Dabrafenib/Trametinib Increased PFS in BRAF-Positive Melanoma | Melanoma Dispatch | Scoop.it

"Data from a phase 3 trial demonstrate combination dabrafenib and trametinib was superior to dabrafenib plus placebo for improved PFS in patients with BRAFV600-positive metastatic melanoma, according to data presented here at the ASCO Annual Meeting.


“ 'This is the first melanoma trial, phase 3, to have an active control arm,' researcher Georgina V. Long, BSc, PhD, MBBS, FRCP, oncologist at Melanoma Institute Australia at the University of Sydney, said of the COMBI-D trial."


Editor's note: This story describes the results of a clinical trial, in which volunteer patients are help test a new treatment. The treatment consists of a combination of the targeted therapy drugs dabrafenib and trametinib. Patients treated with the combination lived longer without progression of their cancer than patients who received dabrafenib plus a non-active placebo. Importantly, these results are specific to patients whose tumors have "BRAF V600E" mutations, which doctors can detect via molecular testing.

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Healio  |  Jun 2, 2014

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Blistering Sunburns in Adolescence Linked with 80% Higher Risk for Melanoma

Blistering Sunburns in Adolescence Linked with 80% Higher Risk for Melanoma | Melanoma Dispatch | Scoop.it

"The risk for developing melanoma is significantly linked with severe sunburns before age 20 years among young white women, according to recent findings.


"Specifically, the risk for onset of melanoma in adulthood was increased by 80% among those who suffered at least five blistering sunburns between the ages of 15 and 20 years."

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Healio  |  May 29, 2014

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Rare Skin Cancer on Palms and Soles More Likely to Come Back Compared to Other Melanomas

Rare Skin Cancer on Palms and Soles More Likely to Come Back Compared to Other Melanomas | Melanoma Dispatch | Scoop.it

"A rare type of melanoma that disproportionately attacks the palms and soles and under the nails of Asians, African-Americans, and Hispanics, who all generally have darker skins, and is not caused by sun exposure, is almost twice as likely to recur than other similar types of skin cancer, according to results of a study in 244 patients.


"The finding about acral lentiginous melanoma, as the potentially deadly cancer is known, is part of a study to be presented May 31 by researchers at the Perlmutter Cancer Center of NYU Langone at the annual meeting of the American Society of Clinical Oncology in Chicago."

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Medical Xpress  |  May 29, 2014

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Patients with Primary Invasive Melanoma at Increased Risk for Subsequent Invasive Melanoma

Patients with Primary Invasive Melanoma at Increased Risk for Subsequent Invasive Melanoma | Melanoma Dispatch | Scoop.it

"Patients with a primary invasive or in situ melanoma had a significantly increased relative risk for developing a subsequent invasive melanoma, according to recent study results.


"Danny R. Youlden, BSc, and fellow researchers used population-based data for melanoma diagnoses collected by the Queensland Cancer Registry in Australia to conduct a retrospective cohort study. All Queensland residents aged 15 years and older diagnosed with a first primary invasive or in situ melanoma between 1982 and 2005 were included. There were 39,668 cases of first primary invasive melanoma (55.8% male) and 22,845 cases of first primary in situ melanoma (54.4% male) identified through 2010."

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Healio  |  May 19, 2014

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Exact Outline of Melanoma Could Lead to New Diagnostic Tools, Therapies

Exact Outline of Melanoma Could Lead to New Diagnostic Tools, Therapies | Melanoma Dispatch | Scoop.it

"A specific biochemical process that can cause normal and healthy skin cells to transform into cancerous melanoma cells has been found by researchers, which should help predict melanoma vulnerability and could also lead to future therapies. They discovered in this situation that the immune system is getting thrown into reverse, helping to cause cancer instead of preventing it."

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ScienceDaily  |  May 8, 2014

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UPDATE 1-EU Agency Backs Approval of New GlaxoSmithKline Melanoma Drug

"GlaxoSmithKline's melanoma drug Mekinist - one of several drugs being sold to Novartis under an asset swap deal - has been recommended for approval by European regulators.


"The European Medicines Agency (EMA) said on Friday its experts had backed the drug, also known as trametinib, as a treatment for unresectable or metastatic melanoma in patients with a mutation of a gene known as BRAF."

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Reuters  |  Apr 25, 2014

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