The U.S. Food and Drug Administration (FDA) has approved a drug to be used to treat patients with advanced melanoma, the latest stages of the deadliest form of skin cancer.
The generic name for the drug is pembrolizumab. New Jersey-based company Merck & Co. developed the treatment specifically for patients with advanced melanoma or melanoma that cannot be treated through surgery, as well as patients who stop responding to other drugs.
The new treatment is administered as an injectable and is only the third drug approved for melanoma that targets the immune system. The drug works by blocking a cellular pathway, known as PD-1, which inhibits the body’s immune system from attacking melanoma cells. By taking the injectable, a melanoma patient’s immune system essentially turns back on and is able to attack the cancerous cells.
Scientists have known about PD-1, which stands for programmed cell death, for quite some time, but they said that it has been challenging trying to create a drug that could affect it.
In clinical trials, scientists tested the pembrolizumab injectable in 173 people with advanced melanoma, whose disease had progressed despite receiving previous treatment. All patients were either given the recommended dose of 2 mg/kg, or a higher dose of 10 mg/kg.
The results of the trials showed that the drug was effective in shrinking cancerous tumors in all patients. The tumor shrinkage lasted nine months or longer among most patients, researchers said.
A separate trial involving 411 patients with advanced melanoma resulted in the drug being deemed safe. Researchers found that most common side effects included fatigue, itchy skin and join pain. Researchers warned that the drug could lead to more serious side effects involving the immune system, although such side effects were rare among the 411 participants.
Another downside of the drug is its cost. Currently, the new drug will cost melanoma patients about $12,500 a month, according to the website FiercePharma. Merck & Co. does, however, offer a patient assistance program which provides financial assistance to patients whose income meets the program’s criteria.