European Commission Approves Erbitux for Head and Neck Cancer Treatment

Strategic Insights -

The European Commission has granted marketing authorization to extend the use of Erbitux (Cetuximab) in combination with radiotherapy for patients with locally advanced squamous cell carcinoma of the head and neck. This development marks a significant advancement for patients with head and neck cancer, with Erbitux being the first and only monoclonal antibody approved for this indication. The approval was based on data from a randomized, international phase III trial, demonstrating an improvement in overall survival for patients treated with Erbitux and radiation. This approval will make Erbitux available for the treatment of head and neck cancer in all 25 member states of the European Union as well as Iceland and Norway.

Key Takeaways:

  • ImClone Systems, Inc. (IMCL) has announced that Merck, KGaA, has been granted marketing authorization by the European Commission to extend the use of Erbitux (Cetuximab) in combination with radiotherapy for head and neck cancer.
  • Erbitux is the first and only monoclonal antibody approved for head and neck cancer, with the approval based on data demonstrating an improvement in overall survival.
  • The approval was achieved in one of the largest studies ever conducted in head and neck cancer, part of a broad evidence-based development plan for Erbitux aimed at demonstrating the therapy's potential in treating human cancers.
  • Erbitux will be available for the treatment of head and neck cancer in all 25 member states of the European Union as well as Iceland and Norway in accordance with local legal regulations.
  • Erbitux is already licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy.
  • The license application was based on the results from a randomized, international phase III trial (IMCL-9815), conducted by ImClone Systems and Merck, KGaA.
  • The trial examined the impact of combining Erbitux with radiation on overall survival and locoregional control in 424 patients with locally or regionally advanced squamous cell cancer of the head and neck.
  • Joseph L. Fischer, interim CEO of ImClone Systems, stated that the approval of Erbitux by the European Commission is a significant advancement for patients with head and neck cancer.

Statistics:

  • 424 patients participated in the randomized, international phase III trial (IMCL-9815) examining the impact of combining Erbitux with radiation on overall survival and locoregional control.
  • The trial was conducted by ImClone Systems and Merck, KGaA.
  • Erbitux will be available for the treatment of head and neck cancer in 27 countries: 25 member states of the European Union, Iceland, and Norway.
  • Erbitux is licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy.

Sources:

  • World Disease Weekly editors, "European Commission Approves Erbitux for Head and Neck Cancer Treatment," Copyright 2006, World Disease Weekly via NewsRx.com.