Genmab provides update on potential regulatory pathway for zalutumumab

Genmab provides an update on the potential regulatory pathway for zalutumumab.

• Genmab has received preliminary feedback from selected national European regulatory authorities and FDA on zalutumumab
• Genmab believes a MAA for zalutumumab in second line head and neck cancer could be pursued based on available clinical data
• Additional clinical study data would be required prior to a US regulatory submission

Genmab A/S (Copenhagen:GEN) announced today an update on the potential regulatory pathway for zalutumumab following preliminary, non-binding discussions with a number of selected national European regulatory authorities and the FDA. Based on overall feedback from regulatory authorities in Europe, Genmab believes a Marketing Authorization Application(MAA) for zalutumumab could be pursued based on the data from the Phase III study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who failed standard platinum-based therapy, reported earlier this year. Additional clinical study data would, however, be required prior to submitting a regulatory application in the US.

"Our discussions with the regulatory authorities have been very productive and we are encouraged by the overall feedback we have received," said Prof. Jan vande Winkel, Ph.D., Chief Executive Officer of Genmab. "We are advancing our partnership discussions in earnest and feel confident that our potential future development partner would be able to move forward with a European regulatory filing for zalutumumab."