GEN Exclusives

More »

GEN Exclusives

More »
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.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Companion Animal Care

Do you think Americans spend too much on companion animal care?