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FDA Greenlights First Treatment for Advanced Skin Cancer

The FDA recently approved the use of Libtayo (cemiplimab-rwlc), an intravenous drug designed for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for curative surgery or curative radiation. Just in the United States, there are more than 700.000 new cases discovered each year, making CSCC the second [...]

The FDA recently approved the use of Libtayo (cemiplimab-rwlc), an intravenous drug designed for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for curative surgery or curative radiation.

Just in the United States, there are more than 700.000 new cases discovered each year, making CSCC the second most common human cancer and accounting for about 20% of all diagnosis. People who are constantly exposed to ultraviolet radiation from the Sun or other sources develop ulcers or hard lumps with scaly tops. Most of the time, surgical resection is enough, but for approximately 5% of patients who develop an advanced form, no treatment is effective.

Libtayo is a programmed cell death protein 1 (PD-1) that targets a certain pathway which prevents the immune system from fighting cancerous cells. The drug is part of the new wave of immunotherapy medicines hailed as being safer for patients, generally more efficient and able to take on situations where other treatments failed.

In a press release, Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence said: “We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the PD-1 / PD-L1 pathway for treating a variety of tumors, from the bladder to head and neck cancer, and now advanced CSCC”.

The decision comes following two successful clinical trials with more than 100 total participants. Libtayo was able to shrink or completely remove tumors in 47% of patients.

Common side effects include fatigue, rash, and diarrhea.

Find out more information here.

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