Emboldened by recent talks with regulators, Denmark's Genmab says its cancer drug zalutumumab looks like its nearing the point at which it can be filed for an approval in Europe. But it looks like the FDA will need new studies costing hundreds of millions of dollars before it offers a green light in the U.S.--and that will take a deep-pocket partner to finance.
"The crucial thing now is to find a partner in the U.S. so that we can go further with this process," CEO Jan van de Winkel told Reuters this morning. Earlier this year, the antibody produced promising results in a Phase III study of patients with recurrent or metastatic squamous cell carcinoma of the head and neck who failed standard platinum-based therapy. That's the data that may be at the heart of Genmab's European app.
"Our discussions with the regulatory authorities have been very productive and we are encouraged by the overall feedback we have received," van de Winkel says in a statement. "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."
Genmab is already partnered with GlaxoSmithKline on a project, and from time to time this year, rumors have circulated that GSK could make a move to acquire the Danish antibody company. So far, that story has never advanced beyond the usual scuttlebutt.
- here's the Genmab release
- get the story from Reuters