Zalutumumab regulatory update

Genmab said it believes an MAA for second-line head and neck cancer candidate zalutumumab in Europe could be pursued based on available data, but that an additional clinical study would be required prior to a submission in the U.S. Genmab made the announcement after meeting with FDA and selected national regulatory authorities in Europe. The company, which announced plans last month to partner zalutumumab, said it expects the new partner would be responsible for the European submission (see BioCentury, Sept. 20). ...