FDA Approves New Advanced Skin Cancer Drug

skin cancer drug

There are literally over a hundred types of cancer that have been identified by the American Cancer Society to date. In addition, cancer is the second leading cause of death in the United States, right behind heart disease, and accounts for roughly 575,000 deaths per year.

Just a couple of days ago, the United States Food and Drug Administration (FDA) announced its approval of a new drug designed to fight advanced cases of basal cell carcinoma, the most common form of skin cancer. Erivedge (generic name: vismodegib) is intended to treat cases of basal cell carcinoma where the cancer has already spread throughout the body, or metastasized, and are unable to be surgically removed. Erivedge is the first advanced skin cancer drug to ever pass the stringent FDA approval process.

Clinical Trials Evaluating Erivedge’s Efficacy and Effectiveness

In a recent clinical trial, 96 individuals with advanced skin cancer were given one pill of Erivedge per day. Of the individuals with metastatic cancer, defined as cancer that has spread to the farthest reaches of the body, 43% experienced significant shrinkage or complete healing of their tumors. Meanwhile, 30% of the individuals with locally advanced basal cell carcinoma, which is less advanced than metastatic cancer, experienced the same type of tumor shrinkage or healing.

“A Nonsurgical Medical Option” for “Very Advanced Cases”

Dr. Desiree Ratner, a leading dermatologic surgeon at New York’s Columbia University Medical Center, described the findings as “exciting.” She said that although she has treated “high-risk” advanced skin cancer cases in the past with surgery, the availability of a “nonsurgical medical option” for “large, very advanced cases” will be a huge asset in the battle against cancer.

Ratner cited an example of a former patient who had an enormous tumor covering her back and neck. Ratner said that surgery was impossible in this case, though Erivedge may have been effective. Erivedge will also be more appropriate than surgery in cases where surgery would permanently disfigure the patient, or where a tumor has spread to the brain.

About Basal Cell Carcinoma

Basal cell carcinoma is the most common form of skin cancer in the United States, accounting for roughly 80% of cases. The cancer starts in the epidermis and spreads very slowly. Roughly 2 million Americans are diagnosed with basal cell carcinoma every year, though just 1% of those cases are metastatic.

The most prominent contributing factor to basal cell carcinoma risk is excessive sun exposure, with related risk factors that include fair skin and freckles.

How Does Erivedge Work?

Basal cell carcinoma is closely related to gene mutations that occur in the hedgehog pathway, a signaling pathway. Erivedge works simply by inhibiting this pathway.

A number of other clinical trials are currently underway to determine whether Erivedge will be useful in treating other forms of cancer. So far, it’s believed that the drug has the potential to treat a certain type of lung cancer, pancreatic cancer and medulloblastoma, a type of child brain cancer.

According to the FDA, Erivedge does come with a number of possible side effects including:

  • Loss of taste

  • Vomiting

  • Nausea

  • Reduced appetite

  • Fatigue

  • Weight loss

  • Hair loss

  • Muscle spasms

As part of the FDA approval process, the organization warned that pregnant women should never take Erivedge.

How Much Will Erivedge Cost?

Representatives from Genentech, the company responsible for Erivedge, have stated that the drug will cost $7,500 for a month’s worth of daily treatments. They said the average patient will require 10 months of treatment, bringing the total cost of the drug to roughly $75,000 for a full course of treatment.

Erivedge: The Bottom Line

The FDA has just approved a new drug proven to treat basal cell carcinoma, the most common type of skin cancer by a large margin. Erivedge, the new drug, has a success rate of roughly 30% to 43% depending on the degree to which the cancer has advanced. The drug has a typical list of side effects and costs $7,500 per month.

A press release detailing the FDA’s approval of the drug can be found here.

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