CHMP 支持 Regeneron 的 Libtayo 在欧盟全部已批癌症适应症采用更低频次给药方案

Regeneron Pharmaceuticals, Inc. (REGN) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending an updated dosing regimen for Libtayo (cemiplimab) across all approved indications in the European Union.
Libtayo is an immunotherapy used to treat several cancers, including certain forms of skin cancer, non-small cell lung cancer and cervical cancer. The treatment works by targeting the PD-1 pathway, helping the immune system recognize and attack cancer cells.
The CHMP recommendation supports a reduced dosing frequency after the first 12 weeks of treatment. Under the proposed regimen, patients would receive Libtayo 350 mg every three weeks for the initial 12 weeks, followed by a higher 700 mg dose administered once every six weeks as a 30-minute intravenous infusion.
The recommendation also supports an optional reduction in infusion time for the 350 mg dose. Patients who tolerate their first 30-minute infusion at this dose could receive subsequent infusions over 15 to 30 minutes, potentially reducing treatment time by up to half.
According to Regeneron, the recommendation was supported by pharmacokinetic and pharmacodynamic modeling and simulation data along with clinical safety and efficacy data from the Libtayo development program.
The European Commission is expected to make a final decision on the application in the coming months. If approved, the updated regimen would be available across all six currently approved Libtayo indications in the European Union.
Libtayo is currently approved in more than 30 countries for one or more cancer indications, including advanced basal cell carcinoma, cutaneous squamous cell carcinoma, non-small cell lung cancer and cervical cancer.
Regeneron continues to evaluate Libtayo in additional studies, both as a standalone therapy and in monotherapy and in combination with other cancer treatments across multiple tumor types.
REGN has traded between $566.11 and $859.34 over the past year. The stock closed Thursday's trading at $769.34, up 2.31%.
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