Zevalin to include imaging on label

Idec (IDPH) said that the FDA will require the company to include labeling in the package insert for its Zevalin ibritumomab tiuxetan radioimmunotherapy that describes an imaging step in the protocol for treating patients with refractory B cell non-Hodgkin's lymphoma (NHL) and follicular NHL refractory to Rituxan rituximab. Speaking on a conference call Thursday, Chief Medical Officer Paul Grint said that the company will provide new language on imaging for the label as part of its package of responses to the agency's complete review letter received earlier this month. IDPH said it expects to submit its responses to the FDA by mid-July and believes it will not need to conduct any additional clinical trials prior to approval.

Grint said the agency wants to see imaging used as part of the Zevalin protocol primarily for safety reasons. Under the revised labeling, patients would receive an indium-labeled Zevalin infusion followed by gamma camera imaging at the beginning of their treatment regimen. The imaging data would be used to see where therapeutic Zevalin, which is labeled with the radioactive agent yttrium, would be concentrated in the body. "It will be used for treat/no-treat decisions," he said. For example, he said that physicians could decide not to use Zevalin if a large tumor mass, where Zevalin concentrates, existed next to a normal organ. He added that imaging, which was part of the pivotal trial protocol for Zevalin, did not result in any no-treat decisions during clinical trials. ...