The FDA has approved the first treatment for patients with metastatic cutaneous squamous cell carcinoma who are not candidates for surgery or radiation.
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| The FDA has approved a treatment for the second most common form of skin cancer, which targets the PD-1/PD-L1 pathway -- the sixth cancer drug approved in recent years targeting it. Photo by Juan Gaertner/Shutterstock |
By Allen Cone, UPI
The U.S. Food and Drug Administration has approved the first treatment for an advanced form of the second most common skin cancer.
On Friday, the FDA approved Libtayo for metastatic cutaneous squamous cell carcinoma.
Cutaneous squamous cell carcinoma is the most common form of skin cancer behind basal cell cancer, with approximately 700,000 cases each year, according to the American Academy of Dermatology. It accounts for 20 percent of all non-melanoma skin cancer.
"We're continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in a press release. "This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients."
Libtayo, whose compound is cemiplimab-rwlc, targets proteins found on the body's immune cells and some cancer cells, and is known as PD-1. By blocking this pathway, the body's immune system can fight the cancer cells.
Regeneron Pharmaceuticals, Inc. and Sanofi were approved to sell the drug.
The companies said in a statement that a three-week treatment course would cost $9,100 before copay support or financial assistance from patient support programs.
"Today's FDA decision is great news for patients with advanced CSCC, who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation," said lead trial investigator Dr. Michael R. Migden, a professor in The University of Texas MD Anderson Cancer Center. "Libtayo is an important new immunotherapy option for U.S. physicians to help address a significant unmet need in this patient group."
The FDA has approved six immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway for treating a variety of tumors, including melanoma of the skin, non-small cell lung cancer, kidney cancer, bladder cancer, head and neck cancers and Hodgkin lymphoma. They are also being studied for use against many other types of cancer.
The other approved inhibitors are nivolumab, pembrolizumab, Atezolizumab, Avelumab and Durvalumab.
The squamous cells, which are thin and flat, look like fish scales and are found in the tissue that forms the surface of the skin.
The cancer develops mainly from regular exposure to the sun or other forms of ultraviolet radiation.
Most patients are cured with surgical treatment, but a small percentage of patients develop advanced disease. Advanced CSCC may cause disfigurement at the tumor and complications such as bleeding or infection. It may also metastasize and spread to local lymph nodes, distant tissues and organs.
Libtayo was studied in two clinical trials with 108 patients, including 75 with metastatic disease and 33 with locally advanced disease.
Among those treated with Libtayo, 47.2 percent had their tumors shrink or disappear.
Side effects include fatigue, rash and diarrhea. Thee immune system could be caused to attack normal organs and tissues and can affect the way they work. This can lead to life-threatening situations and death. The therapy can also harm a developing fetus.
The therapy went through the Breakthrough Therapy and Priority Review programs on its way to FDA approval.
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