EMA Signals Positive Opinion for Regeneron’s Cervical Cancer Monotherapy

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Regeneron’s Libtayo® (cemiplimab) following significant results from a Phase 3 trial. Libatayo is a monotherapy for adult patients with recurrent or metastatic cervical cancer on or after platinum-based chemotherapy.

With their positive recommendation, the European Commission (EC) will decide on the approval of the treatment in the next few months.

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Treating Cervical Cancer

The fourth most common cancer among women is cervical cancer, with 604,000 new cases and 342,000 deaths reported in 2020 alone. Nearly every case results from the human papillomavirus (HPV), an extremely common disease that most sexually active individuals contract at some point in their lives. 

Like most cancers, treatments for cervical cancer include surgery and chemotherapy. Among the chemotherapies approved for cervical cancer treatment is Amneal Pharmaceuticals’ alymsys (bevacizumab). Treating various cancers, including cervical, alymsys is a biosimilar to another chemotherapy, Avastin.

Libtayo works through the inhibition of the protein PD-1 on T Cells binding to the cancer cell. As a result, the T-Cell remains free to attack the cancer cell. The European Union previously approved the potential cervical cancer monotherapy for a number of different cancers. These include advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (NSCLC). 

The Phase 3 EMPOWER-Cervical 1 trial compared Libtayo’s efficacy against a researcher’s choice of commonly used chemotherapy in patients with recurrent or metastatic cervical cancer. The trial found that Libtayo reduced the risk of death by 31%, meeting the primary endpoint of overall survival. 

The trial’s results formed the basis of the CHMP’s positive opinion on the monotherapy. Between the findings of the EMPOWER trial and the treatment’s prior approvals, all signs point to another approval from the EC. However, whether the EC will do so or not remains to be seen, though a final decision is expected in the coming months. 

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Author

Max Heirich