Melanoma Treatments in Development
2011
FDA Approval of Roche Melanoma Drug May Come Early
U.S. regulators are moving quickly with Roche's application for targeted melanoma drug venmurafenicb, which could receive approval as early as this week.
August 9, 2011
Bristol-Myers Squibb Melanoma Drug Yervoy Gets EU Approval
U.S.-based Bristol-Myers Squibb Co.(BMY) Thursday said European regulators have approved its new drug to treat patients with metastatic or late-stage melanoma, the most deadly type of skin cancer.
July 14, 2011
Dana-Farber Research Cites Antibody Therapy For Melanoma
A pair of monocional antibodies, intensified formulations of natural disease-fighting proteins, have shown the potential to be more effective when working together to fight advanced, inoperable melanomas, according to the results of a Phase 1 study led by investigators at the Dana-Farber Cancer Institute.
June 8, 2011
Glaxo's Melanoma Cocktail Helps Almost All Patients In First Trial
GlaxoSmithKline (GSK)'s combination of two experimental groups for advanced melanoma helped almost all patients in its first human study, leading it to launch the therapy directly into large trials needed for U.S. approval.
June 4, 2011
3-Bristol, Roche Team Up On Melanoma Study
Bristol-Myers Squibb and Roche Holding AG said they would evaluate their respective cancer drugs as a potential combination therapy for metastatic melanoma.
June 2, 2011
Plexxikon Announces Combination Trials For Vemurafenib In Melanoma
Plexxion Inc. a member of the Daiichi Sanko Group, today announced new clinical trials in metastatic melanoma testing vemurafenib (PLX4032/RG7204) in combination with other state-of-the-art treatments, including an immunologic therapy and in investigational MEK inhibitor.
June 2, 2011
EU Panel Backs Bristol-Myers Squibb's Yervoy Cancer Drug
Bristol-Myers Squibb Co's cancer drug Yervoy received backing Friday from European regulators.
May 20, 2011
Vemurafenib New Drug Application Submitted to FDA For Melanoma
Dailchi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
May 11, 2011
Plexxikon Announces Data Presentations Of Oncology Pipeline, Including Phase 3 Vermurafenib Data, at ASCO 2011 Annual Meeting
Final data from the Phase 3 study (BRIM3) of vemurafenib in metastatic melanoma will be presented in the General Oncology Plenary Session on Sunday, June 5th.
May 18, 2011
Drug Follows Melanoma Wherever It Goes
A nanoparticle that targets melanoma and highlights cancerous tissue is entering an early-stage clinical trial.
February 17, 2011
Genentech Personalized Investigational Medicine Shows Survival Benefit In Advanced Skin Cancer
Genentech, a member of the Roche Group, announced that BRIM3, a Phase III clinical study of RG7204 (PLX4032), met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.
January 19, 2011
Clinical Trial Studies Safety of Malaria Drug for Melanoma Use
Building upon recent laboratory discoveries on resistance by cancer cells to therapies that attempt to starve cancer, scientists at The Cancer Institute of New Jersey (CINJ) are conducting a clinical trial that further explores how to prevent that action.
January 13, 2011
Positive Results From Allovectin-7 Phase 3 Trial In Patients With Metastatic Melanoma
Vical Incorporated today announced a new published summarizing results from the company's completed trials of Allovectin-7 including systemic responses and an excellent safety profile in patients with metastatic melanoma.
January 11, 2011
U.S. FDA Advisory Meetings Through March 31
The FDA said in a notice on Dec 23rd that the meeting to discuss a biologica license application for Ipilimunab has been cancelled.
January 6, 2011
2010
Killing Drug-Resistant Melanoma Requires Combination Therapy
Patients whose melanoma lesions contain a mutation in the BRAF gene were successfully treated with a BRAF-specific inhibitor, PLX4032. Reports of the drug trial described shrinking tumors and improved health.
December 13, 2010
Expanded Access Study Now Open
AIM at Melanoma announces that the Expanded Access Study for the BRAF inhibitor drug RO5185426 (also known as PLX4032 or RG7204) is now open.
December 13, 2011
International Clinical Trial Tests Targeted Drug for Melanoma
Rush University Medical Center has just enrolled the first U.S. patient in an international clinical trial testing a novel drug to treat certain kinds of melanoma, a deadly skin cancer that in its advanced stages currently has few effective treatments.
November 30, 2010
Genentech Reports Promising Phase II Results With New Targeted Approach In Melanoma
Genentech, Inc., a member of the Roche Group, today announced results from a Phase II clinical study of RG7204 (PLX4032), an investigational first-in-class molecule designed to selectively inhibit a cancer-causing, mutated form of the BRAF protein found in approximately half of metastatic melanoma tumors.
November 5, 2010
Breakthrough Melanoma Treatment On Horizon
The world is approaching its first effective treatment for the usually lethal secondary tumours generated by melanoma, and Australia is at the forefront of the research effort.
November 4, 2010
'Promising' melanoma drugs on horizon
Australian and US scientists are to report the "promising" trial results of experimental drugs that can shrink skin cancers.
November 4, 2010
Groundbreaking melanoma clinical trials initiated by Patrys
Patrys Limited (ASX: PAB), which is focused on developing revolutionary treatments for cancer, announced today the treatment of the first patient in a human clinical trial to evaluate PAT-SM6 as a therapy for melanoma.
October 18, 2010
New Melanoma Drug May Shrink Brain Tumors
An experimental melanoma drug from GlaxoSmithKline managed to shrink secondary tumors in the brains of nine patients with advanced disease, according to results of a small clinical trial on Sunday.
October 10, 2010
Immunocore Announces Clinical Trials of New Treatment for Advanced Melanoma in UK and USA
Researchers at Immunocore Limited announced that IMCgp100, a targeted therapeutic for the treatment of advanced metastatic melanoma, has received regulatory and ethics approval and has opened enrollment for clinical trials in the UK and USA.
October 6, 2010
1-AB Science Winds Skin Cancer Study Shortcut
AB Science has won EU and U.S. approval immediately to begin final-stage clinical studies in advanced melanoma, skipping one trial stage and taking the French biotech's number of late-stage product to nine.
October 5, 2010
ZymoGenetics Turns In Stellar IIAa Data On Melanoma Program
More than half of the 40 patients enrolled for the study were alive after one year and patients had survived a median of 12.4 months.
September 29, 2010
Patient -Specific for Metastatic Melanoma May Induce Durable Complete Regression, Study Shows
Hoag Memorial Hospital Presbyterian recently announced encouraging clinical study results for patient-specific vaccine therapy to treat metastatic melanoma.
September 27, 2010
The Depth of Excision of Invasive Melanoma Differs Substantially Among Physicians
A survey done by Memorial Sloan-Kettering Cancer Center in Hauppaugue, N.Y. among over 1,000 dermatologists and melanoma specialists found substantial differences in the way excisions were done.
September 22, 2010
New Drugs Stir Debate on Rules of Clinical Trials
Two cousins developed the same lethal cancer; only one could take part in an experimental drug trial.
September 19, 2010
Rare Victory in Fight Against Melanoma
Clinical-trial results now suggest that a genetically targeted approach could slow the disease's steady march through the body, and separate research reveals why the latest drug being tested may succeed where others failed.
September 7, 2010
Researcher Discovers New Way to Treat Deadly Eye Cancer
A researcher and the University of Colorado School of Medicine has discovered a new way to treat one of the most deadly forms of eye cancer called choroidal melanoma.
August 30, 2010
News Drug For Advanced Melanoma Shrinks Tumors
An experimental targeted cancer drug shrank advanced melanoma tumors in 81 percent of patients with the deadly and hard-to-treat cancer.
August 25, 2010
Bristol-Myers Squibb Company (BMY) Cancer Drug Gets Faster FDA Review
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has accepted, for filing and review, the Biologics License Application for Ipillmumab for the treatment of adult patients with advanced melanoma who have been previously treated.
August 19, 2010
Morphotek Starts Melanoma Treatment Study
Morphotek initiated a phase-I study of Morab-028, its experimental treatment for patients with advanced melanoma.
August 16, 2010
DNA Repair Genes Help Predict Impact of Chemo for Melanoma
A link between the level of active DNA repair genes in melanoma tumours and the effectiveness of chemotherapy for skin cancer patients has been established for the first time by a team of scientists.
August 16, 2010
Virginia Mason says it's first to offer unique cancer treatment
Virginia Mason is the first West Coast facility to offer a procedure called isolated limb infusion to treat metastatic melanoma.
June 25, 2010
Chemoablation of Metastatic Melanoma with RoseBengal Shows Robust Response.
Chemoablation with an injectable 10% solution of rose bengal disodium (PV-10), induces a robust response in a majority of patients with metastatic melanoma, as reported at the 2010 annual meeting of the American Society of Clinical Oncology.
June 9, 2010
Study: Bristol-Myers Squibb's Ipilimumab Increases Survival of Patients with Melanoma
Bristol-Myers Squibb reported at ASCO positive results from a Phase III study showing that overall survival was "significantly extended" in patients with previously treated metastatic melanoma who received ipilimumab. Trial investigator, Steven O'Day, commented: "For the first time, a significant improvement in overall survival has been demonstrated in previously treated advanced melanoma patients in a large, randomized Phase III study."
June 7, 2010
Ipilimumab Compassionate Use Trial for Patients with Unresectable Melanoma Is Now Available
Combination Chemotherapy Treatment Not Effective
A combination of two different chemo-therapy treatments previously approved for the treatment of kidney and liver cancer are not effective against advanced melanoma.
June 7, 2010
Update 2-Vical Cancer Drug Shows Promise in Mid-Stage Trial
Vical Inc reported positive data from a mid-stage trial of its experimental treatment for metastatic melanoma.
May 12, 2010
Woman: New Pill Stopped Cancer
About a patient on PLX4032.
March 9, 2010
A Doctor's Crusade against Cancer
Cogent letters to editor on Dr. Flaherty, melanoma patients, and PLX-4032, beginning with the letter from the President of the AIM at Melanoma Foundation, stressing the need to appreciate that "there is no ‘magic bullet' ... finding treatments will require long-term persistence and effort..."
February 28, 2010
Miracle Drug on the Horizon for Melanoma?
February 24, 2010
A Protein that Fuels Cancer, and a Drug to Fight It
"Normally, a gene called B-RAF produces a protein that spurs cells to multiply only when growth is needed. But a mutation in the gene produces a protein that is defective - perpetually switched on. That leads to the rapid cell growth that characterizes cancer. The drug PLX4032 binds to the defective protein, deactivating it."
February 22, 2010
Tremelimumab Shows Low but Durable Response Rate in Advanced Melanoma
"In a phase II trial in patients with advanced refractory or relapsed melanoma, tremelimumab (CP-675,206) showed a 6.6% objective response rate, with these responses lasting more than six months..."
February 18, 2010
Melanoma Drugs have Unintended Effects in Some Tumors
Dr. R. Marais et al. of UK and US showed in preliminary studies that giving BRAF inhibitors "to patients whose tumors have normal copies of the BRAF gene could actually accelerate tumor growth..."
February 9, 2010
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Pfizer Strengthens Oncology Arm - Analyst Blog
"Recently, Pfizer (PFE) entered into ... agreement with
Switzerland-based Debiopharm Group regarding ... Tremelimumab for the treatment of patients with melanoma.... Globally, the number of melanoma cases is increasing faster than any other cancer."
January 19, 2010
Melanoma Patients: Should You Ask About PARP Inhibitors?
"PARP inhibitors have been of particular interest for patients who have a cancer that is associated with a BRCA mutation, such as those with familial breast or ovarian cancer." (Also some skin cancers.) "Inhibiting PARP makes the cancer cell more susceptible to the chemotherapy. One of these is the drug temozolomide, used to treat ...melanoma."
January 19, 2010
2009
GM-CSF-Based Second-generation Oncolytic Herpesvirus Vaccine Promising for Melanoma
Phase 2 trial has "a 26% response rate for patients with metastatic melanoma treated with a second-generation granulocyte-macrophage colony-stimulating factor (GM-CSF) oncolytic herpes simplex virus (HSV) vaccine."
December 2, 2009
Trial of New Treatment for Advanced Melanoma Shows Rapid Shrinking of Tumors
Dr. P. Chapman on effect of PLX4032 in patients with the BRAF mutation."
September 23, 2009
New Gene-Targeted Drug Offers Hope in Skin Cancer
On PLX4032 from Roche and Plexxikon, as well as on Roche's Avastin.
September 23, 2009
Roche's Avastin Misses Melanoma Goal, After All
"The 214-patient study found the median overall survival in the Avastin arm was 12.3 months, against 9.2 months in the control arm, but there was a 19 percent likelihood that this result happened by chance." Will continue to study drug for melanoma.
September 23, 2009
Roche Says Avastin Melanoma Study Data "Outdated"
"A late-breaking abstract from the ECCO-ESMO cancer congress in Berlin released on Monday had suggested the drug was the first ever to show a significant improvement.... But a last-minute analysis of the clinical data means the picture has now changed."
September 22, 2009
Skin Cancer Blasted with X-rays
"While brachytherapy -- fighting cancer with internal sources of radiation -- has been in use for decades, the Axxent Electronic Brachytherapy System is especially appropriate for treating skin cancers, according to Xoft, because it emits targeted, low-levels of radiation, so there is little or no radiation scatter."
September 7, 2009
Genetic Study Points to Potential Treatment for Melanoma
Dr. Y. Samuels' study. "A survey of genetic changes in melanoma skin cancer has found that nearly one patient in five may have mutations in a gene called ERBB4.... [M]ay make tumors susceptible to therapies that target the mutations. One such drug, lapatinib (Tykerb), which is used to treat some breast cancers, slowed the growth of cells with ERBB4 mutations in the laboratory."
September 8, 2009
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Adjuvant Radiation Therapy May Improve Outcomes of Melanoma
"Researchers from the M. D. Anderson Cancer Center have reported that adjuvant radiation therapy (RT) improves local control of melanoma following therapeutic lymph node dissection for lymph node-metastatic disease and may improve disease-specific survival."
September 4, 2009
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New Genetic Culprit In Deadly Skin Cancer Revealed
"Drawing on the power of DNA sequencing," NIH research identified new genetic mutations involved in melanoma. "A major cause of melanoma is thought to be sun exposure; the ultraviolet radiation in sunlight can damage DNA and lead to cancer-causing genetic changes within skin cells."
September 1, 2009
Breast Tumor Drug Could Treat Many Skin Cancer Cases
Dr. Y. Samuels of US National Human Genome Research Institute and Dr. S. Rosenberg of NCI "are planning a clinical trial of the drug, known as lapatinib or Tyverb, in patients with certain kinds of malignant melanoma, after genetic research suggested their tumours might be susceptible to it. ...This common melanoma mutation, called ERBB4 or HER4, is also present in certain lung cancers, which can be treated with lapatinib."
August 31, 2009
Cancer Vaccines Led to Long-Term Survival for Patients with Metastatic Melanoma
Hoag Memorial Hospital Presbyterian has announced "promising data from a clinical study showing patient-specific cancer vaccines derived from patients' own cancer cells and immune cells were well tolerated and resulted in impressive long-term survival rates in patients with metastatic melanoma whose disease had been minimized by other therapies."
July 28, 2009
PLX-4032, the New Great Hope for Targeted Therapy in Melanoma
"PLX-4032, a Plexxikon drug being co-developed with Roche, has shown remarkable results in a Phase I trial for melanoma and appears poised for rapid progression through Phase II and Phase III testing with perhaps accelerated FDA approval on the horizon.... This Phase I study examined primarily melanoma patients whose tumors were shown on genetic sequencing to contain the V600E mutation."
July 27, 2009
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Gleevec Shows Promise as Targeted Melanoma Treatment
"Gleevec (Imatinib), a target specific cancer treatment drug against KIT oncogene mutations, shows early evidence of efficacy in treating melanomas with susceptible genetic mutations...."
July 28, 2009
Bristol-Myers Buys Medarex Drugmaker for $2.4 Billion (Update3)
"The deal gives Bristol-Myers full ownership of the skin-cancer drug ipilimumab, which it had been developing jointly with Medarex...Ipilimumab, an experimental drug for metastatic melanoma, is in the third and final stage of testing...."
July 23, 2009
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NeoGenomics Enters into Strategic Supply Agreement with Abbott for Development of a Melanoma Cancer Test
"The goal for the new test is to provide the ability to more accurately diagnose malignant melanoma and provide more accurate prognostic information, thus assisting dermatologists in better managing patient care."
July 25, 2009
Taking a Shot at Antigenics
"Oncophage is a revolutionary patient-specific therapeutic vaccine ....[S]tudied in phase III trial for metastatic melanoma...."
July 23, 2009
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Breast Cancer Drug Abraxane Promising for Malignant Melanoma Treatment
"An approved breast-cancer drug nab-paclitaxel, trade named Abraxane, has been found promising in clinical trial for the treatment of metastatic malignant melanoma...."
July 20, 2009
Roche to Present Major Advances with Targeted Cancer Medicines at ASCO [American Society of Clinical Oncology]
Roche and Plexxikon "will present promising results from a Phase I trial of PLX4032/R7204. This is a highly selective medicine that targets the mutated cancer-causing BRAF protein that occurs in 60% of melanoma (skin) cancers...."
May 18, 2009
Ipilimumab Linked to Melanoma Survival: Studies
"More than a third of advanced melanoma patients treated with ipilimumab, an antibody being developed by Bristol-Myers Squibb Co (BMY.N) and Medarex Inc (MEDX.O), continued to survive after 18 months...."
May 14, 2009
Synta Pharmaceuticals Announces First Patient Treated in Elesclomol Monotherapy Solid Tumor Clinical Study
First patient treated for a study of elesclomol as the sole agent.
Mentions other ongoing trials of the drug in combination with other drugs, such as paclitaxel for melanoma.
February 10, 2009
Tremelimumab Dose Selected for Further Testing
"......due to favorable safety,tumor response in melanoma."
January 27, 2009
Synta, Developer of New Class of Cancer Drugs, Eagerly Awaits Results from Key Trial
Synta in suspense still for some weeks on whether its drug elesclomol is a breakthrough in treating melanoma. History of Synta.
January 27, 2009
2008
UVA Damage May Be Prevented by Astaxanthin
“Astaxanthin is more efficient than other carotenoids in protecting the skin from UV damage,” from a lab study at San Gallicano Dermatology Institute in Rome.
November 3, 2008
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Updated Survival Data from Three Phase 2 Ipilimumab Studies Showed Almost Half of Previously Treated Metastatic Melanoma Patients Alive Beyond One Year
Bristol-Myers Squibb Data Presented at 33rd Congress of the European Society for Medical Oncology. First half of page is blank. Discusses 3 phase-2 studies.
September 15, 2008
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Elesclomol Two-Year Survival and Integrated Safety Data Presented at the 33rd Congress of the European Society for Medical Oncology
September 15, 2008
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Sanofi Launches Phase 2 Study of Melanoma Treatments
“120 patients are being enrolled in the United States and Canada for the trial, called ‘MEL11,’" a therapeutic cancer vaccine.
September 17, 2008
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No Benefit for Extended-Schedule Temozolomide in Treating Advanced Melanoma: Presented at ESMO
From study at 92 institutions in Europe, US and Latin America, presented at European Society for Medical Oncology Congress.
September 15, 2008
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