According to a story from BioSpace, the biopharmaceutical company Merck recently announced that the US Food and Drug Administration (FDA) has approved the company’s cancer drug KEYTRUDA in a new indication as a therapy for metastatic or locally advanced Merkel cell carcinoma, which is a rare form of skin cancer that can be challenging to treat effectively. This decision from the agency falls under accelerated approval.
About Merkel Cell Carcinoma
Merkel cell carcinoma is a type of skin cancer that is known for its rarity and aggressiveness. In most cases, roughly 80 percent, the disease is caused by Merkel cell polyomavirus (MCV). Tumors of this cancer are infected with the virus when it is found to be the cause. In the remaining cases, exposure to sunlight or UV light may be part of the cause, as it can often appear alongside other more common types of skin cancer. Signs and symptoms include a small painless skin nodule, that may be red or blue in color and enlarge rapidly. Merkel cell carcinoma can metastasize rapidly to the lymph nodes or other internal organs. Treatments for this cancer include surgery, chemotherapy, and radiation therapy. More targeted therapies are currently being tested. Curing the cancer is very difficult once metastasis has occurred. The five year survival rate for this disease is around 60 percent. To learn more about Merkel cell carcinoma, click here.
Clinical Trial Findings
In clinical trials, KEYTRUDA was able to induce a response rate of 56 percent in Merkel cell carcinoma patients, with 24 percent of patients displaying a complete response. The partial response rate to KEYTRUDA was 32 percent. It should be noted that KEYTRUDA can affect the activity and function of the immune system, and users at an increased risk of infections or other serious reactions. The patients in the study had not received systemic therapy for their cancer before the study began.
96 percent of patients who saw response achieved duration of response that was greater than six months; however, only 24 percent of patients achieved duration of response for a year or more.
Overall, the approval will give patients with this rare form of skin cancer another option for treating their advanced disease.
