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Health & Medicine for Senior Citizens

FDA Approves Drug Combo to Treat Advanced Melanoma Found Most Often in Seniors

Mekinist in combination with Tafinlar is new hope for those with advanced melanoma; 76% success is shrinking, killing cancer

Jan. 14, 2014 -The U.S. Food and Drug Administration has approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage). Melanoma rates are highest in older people aged 55-64 years. The median age is 61. But deaths are highest in senior citizens aged 75-84 years with the median age being 69.

In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma. Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease. The National Cancer Institute estimated that 76,690 Americans would be diagnosed with melanoma and 9,480 would die from the disease in 2013.
 

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See more links below news report.


 
 

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Mekinist and Tafinlar are used to block signaling in different sites of the same molecular pathway that promotes cancer cell growth. They are specifically indicated as a combination therapy for patients with melanoma whose tumors express gene mutations called BRAF V600E and V600K. The BRAF protein is involved in the regulation of normal cell growth, but it is mutated in approximately half of melanomas arising from the skin.  

“Mekinist and Tafinlar are the first drugs approved for combination treatment of melanoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Their development for combination use is based on the strong understanding of the biological pathways of the disease. This approval illustrates the value of continuing to study drugs in combination for clinical development.”

The safety and effectiveness of Mekinist in combination with Tafinlar were demonstrated in a clinical trial of 162 participants with unresectable or metastatic melanoma with the BRAF V600E or V600K mutation, most of whom had not received prior therapy. Participants received either Mekinist in combination with Tafinlar or Tafinlar as a single agent until their melanoma progressed or side effects became intolerable.

Results showed that 76 percent of participants treated with Mekinist in combination with Tafinlar had their cancer shrink or disappear (objective response) that lasted an average of 10.5 months. In contrast, 54 percent of participants treated with Tafinlar as a single agent experienced objective responses that lasted an average of 5.6 months. Clinical trials are ongoing to determine whether Mekinist in combination with Tafinlar improves survival.

The most common side effects reported in participants receiving Mekinist in combination with Tafinlar included fever, chills, tiredness, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema (swelling in the hands and feet), cough, headache, joint pain, night sweats, decreased appetite, constipation and muscle pain. During clinical testing, the incidence and severity of fever increased when Mekinist was used in combination with Tafinlar.

About Melanoma (MedlinePlus)

Melanoma is the most serious type of skin cancer. Often the first sign of melanoma is a change in the size, shape, color, or feel of a mole. Most melanomas have a black or black-blue area. Melanoma may also appear as a new mole. It may be black, abnormal, or "ugly looking."

Thinking of "ABCDE" can help you remember what to watch for:

Asymmetry - the shape of one half does not match the other

Border - the edges are ragged, blurred or irregular

Color - the color is uneven and may include shades of black, brown and tan

Diameter - there is a change in size, usually an increase

Evolving - the mole has changed over the past few weeks or months

Surgery is the first treatment of all stages of melanoma. Other treatments include chemotherapy and radiation, biologic, and targeted therapies. Biologic therapy boosts your body's own ability to fight cancer. Targeted therapy uses substances that attack cancer cells without harming normal cells.

NIH: National Cancer Institute

In 2013, it is estimated that there will be 76,690 new cases of melanoma of the skin and an estimated 9,480 people will die of this disease.

Who Gets This Cancer?

Melanoma is more common in men than women and among individuals of fair complexion and those who have been exposed to natural or artificial sunlight (such as tanning beds) over long periods of time. There are more new cases among whites than any other racial/ethnic group. The number of new cases of melanoma of the skin was 21.1 per 100,000 men and women per year.

More Links:

JAMA Patient Page: Melanoma(American Medical Association) - PDF

Melanoma(American Academy of Dermatology)

What Is Melanoma Skin Cancer?(American Cancer Society)

Melanoma: What It Looks Like(American Academy of Dermatology)

Melanoma(American Academy of Dermatology)

What Is Melanoma Skin Cancer?(American Cancer Society)

Serious side effects included bleeding, clot formation, heart failure, skin problems and eye problems. One of the serious side effects of Tafinlar—the development of a new squamous cell carcinoma of the skin—was reduced when the drug was used in combination with Mekinist; this is consistent with the biology of the effects of these two drugs on the targeted molecular pathway.

The incidence of squamous cell carcinoma of the skin in this trial was 7 percent with the combination compared to 19 percent with single agent Tafinlar. Other clinically significant side effects include kidney injury.

Women of child bearing potential should be advised that Mekinist and Tafinlar can cause birth defects in a developing fetus.  Men and women should also be advised that Mekinist and Tafinlar treatment may cause infertility.

The FDA approved the combination of Mekinist and Tafinlar under the agency’s accelerated approval program, which allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.

This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. The FDA also reviewed this combination of drugs under the agency’s priority review because they demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

Mekinist and Tafinlar are marketed by GlaxoSmithKline, based in Research Triangle Park, N.C.

For more information:


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 


Links to More Archived Stories on Melanoma Cancer

Nobody Should Die from Advanced-Stage Melanoma, Says Leading Researcher

Tide is turning in skin cancer battle with more than 100 promising drugs for blocking cancer-causing signaling pathways

July 16, 2013

Fast Acting Virus Kills Melanoma Cancer Cells Before Immune System Can Stop It

Melanoma killer has been highly efficient attacking human cancer cells in animals, lab tests, while ignoring healthy ones

April 23, 2013

Immune System Uses Melanoma's Own Proteins to Kill Off Cancer Cells, Researchers Say

Transfer of cancer building cells to immune system provides crucial intelligence about the attacking cancer, which facilitates the right defense to kill the cancer - Feb. 4, 2013

Earlier Detection of Cancer May Be Enhanced by MIT Discovery with Biomarkers Collected in Urine

Nanoparticles amplify tumor signals, making them much easier to detect in urine - Dec. 17, 2012

Small Test Shows Treatment’s Potential to Stop Spread of Melanoma Cancer

Treatment uses drug believed capable of stimulating a patient’s immune system into attacking cancer cells while sparing healthy normal tissue - Nov. 16, 2012

How Melanoma Skin Cancer Can Resist Chemotherapy is Discovered

Study results suggest new approach to treating most deadly skin cancer - Sept. 17, 2012

Discovery of Biomarker for Deadly Melanoma Skin Cancer Offers New Hope

Researchers were able to reverse melanoma growth in pre-clinical studies  - Sept. 13, 2012

Melanoma Skin Cancer May Be More Treatable with New Discovery

Average age of melanoma diagnosis is 61; over 9,000 expected to die in 2012 - more about this skin cancer below news report - Aug. 15, 2012

Secret to Melanoma Cancer’s Resistance to Treatment Exposed - Hope for Seniors

After melanoma removed from head...Researchers say they have found why treatment is difficult and may have answer for turning this around - July 23, 2012


Aspirin, Painkillers Ward Off Skin Cancer; Second Study Lets Immune System Stop Melanoma

NSAIDs decreased risk for squamous cell carcinoma and malignant melanoma; advanced melanoma patients see scientist lower cancer barrier to allow immune system attack - May 29, 2012


Early Success in Curing Melanoma in Mice Spurs Mayo Vaccine Development

Success with melanoma adds to Mayo Clinic's growing portfolio of experimental cancer vaccines - March 19, 2012


New Therapies May Mean More Life for Patients with Advanced Melanoma

Two new drugs, vemurafenib (Zelboraf) and ipilimumab (Yervoy), showing promise in slowing the progression of this skin cancer - March 16, 2012


Metastatic Melanoma Patients Live Almost Twice as Long with New Drug

Zelboraf (vemurafenib) changes the natural history of the disease to extend survival - see video - Feb. 23, 2012


Cancer Survivors Face Increased Risk of Melanoma; Melanoma Survivors Even More

Melanoma the most aggressive, dangerous skin cancer, fifth most common cancer among men, seventh among women - Dec. 19, 2011


Pre-Melanoma Skin Lesion Found Mostly in Elderly Successfully Removed with Laser

Lentigo maligna disappears as carbon dioxide laser exerts its effect by vaporization of water-containing cells - Nov. 21, 2011


Coffee, Favorite Drink of Seniors, Provides Protection from Basal Cell Carcinoma

Women get almost twice as much protection as men among 3-cup a day drinkers - see video - Oct. 26, 2011


Senior Citizens Facing Melanoma Should Worry More About Their Health Than Their Age

Patients with lower muscle density had much higher rates of their cancer returning – regardless of the tumor size or patient's age - Aug. 30, 2011


Vitamin D Appears Linked With Risk of Skin Cancer, Although Relationship Complex

Study looked at vitamin D level in senior citizens with non-melanoma skin cancers - Aug. 15, 2011


Melanoma Skin Cancer a Chronic Disease Causing Long-Term Problems for Women

Women need additional care, including follow-up and possibly counseling to optimally cope with melanoma - Feb. 21, 2011


 

Financial Relief for Volkswagen Diesel Owners

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In the major scandal of 2015, Volkswagen cheated you and the world. They rigged diesel emission controls so you, nor regulators, would know how much pollution their cars were adding to our environment.

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Audi A6, A7, A8, Q5 Quattro (2016)

 

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