Regeneron Scores Key FDA Approval for Libtayo in Skin Cancer
Drug becomes the first and only immunotherapy approved for adjuvant treatment of high-risk cutaneous squamous cell carcinoma, a setting where a top rival failed.
Regeneron Pharmaceuticals (REGN) has secured a significant victory for its blockbuster cancer drug, Libtayo (cemiplimab-rwlc), receiving U.S. Food and Drug Administration (FDA) approval for a new indication in treating a common form of skin cancer. The approval positions Libtayo as the first and only immunotherapy available for adult patients with cutaneous squamous cell carcinoma (CSCC) who are at high risk of their cancer returning after surgery and radiation.
The expanded approval is a critical milestone for Regeneron, opening up a new market segment and further solidifying Libtayo's market position. The decision was based on a pivotal Phase 3 trial that demonstrated Libtayo's effectiveness in the adjuvant setting, a preventative treatment given after initial therapy to reduce the risk of recurrence. In the trial, Libtayo showed a compared to placebo.
This achievement is particularly notable given the competitive landscape. Merck's blockbuster immunotherapy, Keytruda, previously failed in a clinical trial for the same adjuvant CSCC indication, giving Regeneron a clear advantage in this patient population. This win underscores Regeneron's strategic execution in oncology and its ability to carve out a unique space for Libtayo.
The market potential for this new indication is substantial. Regeneron estimates that approximately could be eligible for Libtayo in the high-risk adjuvant setting, a larger addressable market than its existing approvals for advanced disease. This expansion is expected to bolster the drug's already impressive sales trajectory.
Libtayo has already achieved blockbuster status, with , a 41% increase from the prior year. For investors, the continued growth of Libtayo provides a crucial offset to concerns surrounding Regeneron's flagship eye drug, Eylea, which is facing increasing biosimilar competition. Analysts see the strong performance of drugs like Libtayo and Dupixent as key drivers that could lead to an 'upside surprise' in the company's overall revenue growth.
The positive news, coupled with the company's recent initiation of a quarterly dividend and a new share repurchase program, signals management's confidence in its long-term growth prospects. As Regeneron continues to expand Libtayo's label, the drug is set to become an even more critical pillar of the $62 billion biotech's commercial success.