FDA News

FDA approves Libtayo, first drug specifically for advanced cutaneous squamous cell carcinoma

The FDA approved cemiplimab-rwlc for IV treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma.

The approval is the first of a drug specifically for advanced cutaneous squamous cell carcinoma, the second most common skin cancer in the United States.

The approval applies to use of cemiplimab-rwlc (Libtayo; Regeneron, Sanofi) — a fully human monoclonal antibody that targets PD-1 — for patients who are not candidates for curative surgery or curative radiation.

“[This] FDA decision is great news for patients with advanced cutaneous squamous cell carcinoma, who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation,” Michael R. Migden, MD, lead investigator in the pivotal cutaneous squamous cell carcinoma clinical program and professor in the departments of dermatology and head and neck surgery at The University of Texas MD Anderson Cancer Center, said in a press release. “Libtayo is an important new immunotherapy option for U.S. physicians to help address a significant unmet need in this patient group.”

Cutaneous squamous cell carcinoma accounts for approximately 20% of all skin cancers in the United States. An estimated 7,000 Americans die of the disease each year.

The FDA based the approval on results of a combined analysis of data from EMPOWER-CSCC-1 — an open-label, multicenter, nonrandomized phase 2 trial — as well as two advanced expansion cohorts from a nonrandomized, open-label phase 1 study. The analysis included 75 patients with metastatic disease and 33 patients with locally advanced disease.

Results showed a confirmed objective response rate of 47% (95% CI, 38-57) and a 4% complete response rate. All complete responses occurred among patients with metastatic disease.

Some patients had ongoing responses of longer than 15 months at the time of last assessment, and 61% of responses lasted at least 6 months.

Common side effects of cemiplimab-rwlc include fatigue, rash and diarrhea.

The FDA previously granted the agent priority review designation.

The recommended dose is 350 mg via IV infusion administered over 30 minutes every 3 weeks until unacceptable toxicity or disease progression.

The FDA approved cemiplimab-rwlc for IV treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma.

The approval is the first of a drug specifically for advanced cutaneous squamous cell carcinoma, the second most common skin cancer in the United States.

The approval applies to use of cemiplimab-rwlc (Libtayo; Regeneron, Sanofi) — a fully human monoclonal antibody that targets PD-1 — for patients who are not candidates for curative surgery or curative radiation.

“[This] FDA decision is great news for patients with advanced cutaneous squamous cell carcinoma, who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation,” Michael R. Migden, MD, lead investigator in the pivotal cutaneous squamous cell carcinoma clinical program and professor in the departments of dermatology and head and neck surgery at The University of Texas MD Anderson Cancer Center, said in a press release. “Libtayo is an important new immunotherapy option for U.S. physicians to help address a significant unmet need in this patient group.”

Cutaneous squamous cell carcinoma accounts for approximately 20% of all skin cancers in the United States. An estimated 7,000 Americans die of the disease each year.

The FDA based the approval on results of a combined analysis of data from EMPOWER-CSCC-1 — an open-label, multicenter, nonrandomized phase 2 trial — as well as two advanced expansion cohorts from a nonrandomized, open-label phase 1 study. The analysis included 75 patients with metastatic disease and 33 patients with locally advanced disease.

Results showed a confirmed objective response rate of 47% (95% CI, 38-57) and a 4% complete response rate. All complete responses occurred among patients with metastatic disease.

Some patients had ongoing responses of longer than 15 months at the time of last assessment, and 61% of responses lasted at least 6 months.

Common side effects of cemiplimab-rwlc include fatigue, rash and diarrhea.

The FDA previously granted the agent priority review designation.

The recommended dose is 350 mg via IV infusion administered over 30 minutes every 3 weeks until unacceptable toxicity or disease progression.

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