By: Patricia Keegan, M.D.
Skin cancer is the most common form of cancer in the United States and rates of new cases continue to increase, especially in younger populations. Some of that increase may be attributed to greater public awareness about the risks of skin cancer, resulting in more patients inspecting their skin and talking with their doctors about an appropriate diagnosis.
There are three main types of skin cancer: basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma. Melanoma is much less common than basal cell and squamous cell skin cancers but it is far more dangerous – it’s the leading cause of death from skin disease and is emerging as one of the most frequently diagnosed forms of cancer. In 2011, there were an estimated 70,230 new cases and 8,790 deaths from melanoma in the United States.
But last year represented a tremendous leap forward for patients living with late-stage (metastatic) melanoma. For the first time in FDA’s history, we approved two novel therapies that extended the lives of patients (overall survival) with late-stage melanoma. Cancers that spread are frequently more difficult to treat and associated with poor outcomes for patients.
The two treatments, Yervoy (ipilimumab) and Zelboraf (vemurafenib), are not only unique because of their ability to extend a person’s life, but also recognized for the role they play in attacking the cancer itself.
Yervoy blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4 and works with a person’s immune system to recognize, target, and attack cells in melanoma tumors.
In 2011, the FDA approved Zelboraf, a personalized medicine to treat patients with melanoma whose tumors have the BRAF V600E gene mutation. With the aid of an FDA-approved test, patients can be selected to receive treatment with the drug, which blocks the ability of mutated BRAF to make tumors grow.
Today’s approval of Erivedge (vismodegib) for patients with late-stage or advanced basal cell carcinoma is the latest treatment advance for patients with the most common type of skin cancer, which is usually cured by surgery to remove the cancer. The treatment is the first drug approved for the small fraction of patients whose tumors are not controlled by or who cannot receive curative local therapy.
These important and innovative new therapies are encouraging for the millions of patients currently living with a form of late-stage skin cancer. Their availability today for patients is a testament to the ingenuity and dedication of the academic researchers and companies who studied and developed them; the patients willing participate in the investigational trials; and the FDA staff dedicated to timely scientific reviews with an eye to what is best for patients.
Patricia Keegan, M.D., is Director for the Division of Oncology Products 2 in the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research