FDA Approves Drug for Skin Cancer: Truly Effective, or Just Another Money-Maker?
It seems like there’s a pill to treat or cure anything that ails you . . . meaning pharmaceutical profits are through the roof. Often those drugs are semi-effective; sometimes they’re very effective, and sometimes they’re not effective at all.
But could a new drug the FDA just approved actually be the real deal? Or is it just another way to pad Big Pharma's pockets?
Well, it appears a major milestone has been reached in cancer treatment with the FDA approval of Erivedge (vismodegib), the first ever drug approved for the treatment of advanced basal cell carcinoma, which is a form of skin cancer.
What is Basal Cell Carcinoma?
Basal cell carcinoma starts in the top layer of skin and usually develops in those areas that are commonly exposed to UV rays from the sun or other ultraviolet radiation. It’s a slow-growing cancer that is known to be painless in the initial stages. However, BCC can grow to disfiguring proportions and spread to other parts of the body, even causing death.
Skin cancer is the most common form of cancer diagnosed in the United States with basal cell carcinoma being the most common type of skin cancer. It is reported that approximately 3.5 million people are diagnosed with skin cancer every year in the United States and nearly 2.8 million of those are diagnosed with basal cell carcinoma.
Priority Given by the FDA
Drug maker Roche was given the FDA’s approval a month earlier than expected for Erivedge. The drug treatment is specifically for adults whose cancer is not treatable through radiation or surgery, or for those whose cancer has returned or metastasized to other parts of the body following surgery.
The drug was reviewed under a special FDA program that offers expedited review within six months for any drugs that may offer significant medical advances in regard to treatment. Approval in Europe is currently pending.
The initial effectiveness and safety of the drug has been impressive to say the least. Of the 96 patients evaluated, all of who had either locally advanced or metastatic basal cell carcinoma, 30 percent experienced a partial shrinkage of their cancerous lesions and 43 percent experienced a full disappearance of their locally advanced cancer.
Erivedge, which is to be taken once a day for an average treatment time lasting 10 months is expected to cost $7,500 per month for a total of $75,000, according to co-developer, Curis.
Side Effects and Warnings
The approval of the drug comes with a warning for patients and healthcare professionals of a potential risk of severe birth defects or death to a fetus, requiring that the possibility of pregnancy be confirmed prior to starting treatment with Erivedge.
Along with the warning for the potential risk to pregnant women, Erivedge, like all other drugs, does have a list of potential side effects. The most common side effects observed in patients who took the drug as a part of the study were hair loss, muscle spasms, weight loss, gastrointestinal issues such as diarrhea, nausea, vomiting, constipation, and decreased appetite. Fatigue and a loss of taste in the tongue are also listed as potential side effects.
It sounds like Erivedge is on its way to becoming a force to be reckoned with when it comes to treating skin cancer. The fast-track approval by the FDA does raise some concern, however. With such severe side effects known, what is the potential for the unknown? Only time will tell.