ImClone Systems has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for approval of Erbitux (Cetuximab), an IgG1 monoclonal antibody in the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN), ImClone Systems Incorporated and Bristol-Myers Squibb Company announced here.
The application seeks US marketing approval for the use of Erbitux in combination with radiation for locally or regionally advanced SCCHN, and as monotherapy in patients with recurrent and/or metastatic SCCHN where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate. The companies also announced that ImClone Systems has requested priority review of the application.
A randomized, international phase III trial (IMCL-9815), conducted by ImClone Systems and Merck KGaA, Darmstadt, Germany, which examined the impact of combining Erbitux with radiation on locoregional control and overall survival in 424 patients with locally or regionally advanced SCCHN.
An open-label, multi-centre phase II trial (EMR-016), conducted by Merck KGaA, which evaluated the response rate of Erbitux as a single agent in 103 patients with recurrent and/or metastatic SCCHN who have failed platinum-based chemotherapy.
In parallel, Merck KGaA, ImClone Systems' development and marketing partner for Erbitux outside of North America, has filed a Variation Application to the European Medicines Agency (EMEA) and to the Swiss authority (Swissmedic) for approval of Erbitux for the treatment of SCCHN in Europe using a similar filing package to that which was submitted by ImClone Systems and Bristol-Myers Squibb Company.