What's Happening?
Regeneron's Libtayo has received FDA approval as the first checkpoint inhibitor for adjuvant treatment in adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence post-surgery and radiation therapy. This approval extends Libtayo's use beyond its initial indication for advanced CSCC, which was approved in 2018. The drug has also gained FDA approvals for basal cell carcinoma, non-small cell lung cancer, and cervical cancer. The approval is significant as it positions Libtayo in a competitive space where other checkpoint inhibitors, like MSD's Keytruda, have not demonstrated efficacy as adjuvant therapies for high-risk CSCC. The C-POST study, highlighted at the ASCO cancer conference, showed Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo, with 87% of treated patients remaining disease-free at two years.
Why It's Important?
The approval of Libtayo for adjuvant use in CSCC is a major development for Regeneron, as it opens up a larger patient population compared to the advanced disease setting. CSCC is one of the most common skin cancers, with approximately 1.8 million cases diagnosed annually in the U.S. alone. Many patients face a serious risk of advanced disease recurrences, making this approval crucial for improving patient outcomes. The success of Libtayo in the adjuvant setting could lead to increased adoption and sales, as evidenced by its growing momentum in the PD-1/PD-L1 inhibitor category, with sales rising 41% to $1.22 billion last year.
What's Next?
Regeneron has submitted Libtayo for approval in Europe for the adjuvant CSCC indication, with a decision expected in the first half of 2026. This could further expand the drug's market presence and provide more treatment options for patients globally. The approval may also prompt other pharmaceutical companies to explore similar adjuvant therapies for skin cancer, potentially leading to more competitive offerings in the market.
Beyond the Headlines
The approval of Libtayo highlights the ongoing advancements in cancer treatment, particularly in the field of immunotherapy. It underscores the importance of continued research and development in addressing unmet needs in non-melanoma skin cancer. The success of Libtayo may encourage further investment in innovative therapies that can improve survival rates and quality of life for cancer patients.
