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Insight & Intelligence™ : Jun 4, 2009

FDA Orders Partial Clinical Hold on Genmab’s Anticancer Agent

Enrollment in two mid-stage trials with zalutumumab in head and neck cancer halted.

The FDA has put a partial clinical hold on Genmab’s head and neck cancer candidate zalutumumab. FDA also asked for a fresh analysis of safety data from the trials and did not have any specific safety concerns related to particular events, according to a Genmab spokesperson.

Affected ongoing trials include a Phase II study in patients with head and neck cancer considered incurable with standard treatment and a Phase I/II front-line trial assessing zalutumumab in combination with chemo-radiation. As a result of the FDA’s partial halt, patients who aren’t experiencing any serious side-effects will continue to receive zalutumumab treatment but no additional patients will be enrolled into the studies, Genmab explains.

Two ongoing Phase III trials and a Phase I/II study evaluating zalutumumab combined with radiotherapy are not affected, because they are not being conducted under the IND application. One of these, a pivotal, 264-patient Phase III trial in refractory head and neck cancer, is due to report results by the end of 2009.

Zalutumumab is a fully human, high-affinity antibody targeted at the epidermal growth factor receptor (EGFr). It previously was awarded fast track status from the FDA as a treatment for head and neck cancer patients who had previously failed standard therapies.