Oncology biomarker qualification efforts jointly tackled by FDA, the National Cancer Institute and CMS will encompass prospective studies and ongoing clinical trials.

"Tremendous opportunities are being wasted right now because trials are being done [that] could be used as vehicles to study and qualify biomarkers," FDA Deputy Commissioner for Operations Janet Woodcock stated during a conference call Feb. 14 announcing the tri-agency initiative.

"We believe that by pooling resources across sectors we can add on this biomarker qualification work to trials that various entities are doing," Woodcock said.

"With FDG-PET in lymphoma, as well as any other markers we're going to [consider] qualifying, we're going to look at leveraging the work that is going on right now," she commented.

The first prospective study under the Oncology Biomarker Qualification Initiative will evaluate the ability of fluorodeoxyglucose-positron emission tomography to predict early response in non-Hodgkin's lymphoma, the agencies said.

"This demonstration project is just the first one out of the box. We use it as an example of the kind of projects we are going to do under this initiative," Woodcock noted.

The agencies selected non-Hodgkin's lymphoma as an initial disease target because of perceived opportunity to improve survival. There are considerable data on non-Hodgkin's lymphoma, and "we know a lot about the extent to which FDG-PET is predictive in this tumor," National Cancer Institute Deputy Director Anna Barker said.

"It certainly appears to us, based on the evidence to date, that if we could - especially in patients undergoing therapy - predict early response...it would be a huge advantage for patients."

FDG-PET has been established as a good predictor of disease-free and progression-free survival in other types of lymphoma, Barker added.

"This is one of those areas where we could actually have some very, very quick progress in the sense that we would be able to actually use this - we hope - as an endpoint for early response" and, perhaps, for clinical outcome, she stated.

A preliminary protocol is in place for the FDG-PET in non-Hodgkin's lymphoma study and a meeting of experts to finalize the study design is scheduled for March 20.

"This is a very technically challenging area and we want the best of the imagers and the best of the lymphoma experts to sit down together and really once and for all - working with folks from FDA and CMS - sort out all of the issues that need to be considered when you design a trial like this," Barker said.

"There may be more than one trial, by the way. It is unlikely that we will be able to answer all the questions we have with one trial," she added.

NCI will determine which of its ongoing lymphoma trials could accommodate a biomarker qualification component at the trial design meeting.

"What we plan to do through this initiative is conduct multiple projects through various venues - through private and public collaboration in many places - to get this kind of qualification work done," Woodcock said.

Woodcock noted that there are numerous opportunities to conduct qualification work for biomarkers in the oncology field, including the validation of PET scans in other tumor types. "We're going to start with a selected cancer, but we're going to expand that out to include other cancers," Barker added.

FDA has made biomarker development a priority under its Critical Path initiative, which would receive funding for the first time under the President's 2007 budget request (¹ Also see "President’s Budget Paves The Critical Path With $6 Mil. Request" - Pink Sheet, 13 February, 2006., p. 9). The oncology project is expected to be included in the agency's Critical Path initiative opportunities list.

The agency plans to issue individual guidances for qualified biomarkers and is working to develop a general pathway for biomarker qualification (² Also see "Biomarkers To Get Individual Guidances Under FDA Plan To Promote Development" - Pink Sheet, 17 October, 2005., p. 20).

Tri-Agency Oncology Biomarker Initiative Commences With PET Scan Study

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