It's not often that a high-ranking Food and Drug Administration official publicly requests that a company submit a diagnostic for FDA approval, but Larry Lesko, director of the Office of Clinical Pharmacology and Biopharmaceuticals at the agency's Center for Drug Evaluation and Research, came pretty close during a talk at the Bio-IT World conference in Boston last week.
During a keynote address outlining the FDA's current pharmacogenomics initiatives, Lesko cited Genomic Health's Oncotype Dx as an example of a promising model for pharmacogenomics-based diagnostics, and noted that although the test has not yet been submitted to the FDA for approval, the agency would "like them to bring it in."
While the comment was almost certainly an off-hand remark, it was the only commercial product that Lesko mentioned during his talk that had not yet received FDA clearance. That notice heaps just a bit more attention on Redwood City, Calif.-based Genomic Health, whose Oncotype Dx breast cancer assay was presented in three independent studies at last week's American Society of Clinical Oncology in Orlando, Fla., one of which was selected by the ASCO Cancer Education Committee for the "Best of Oncology" session.
"In a case like that, it's definitely movement in the right direction for personalized medicine," Felix Frueh, associate director of the CDER and head of the FDA's Interdisciplinary Pharmacogenomics Research Group, told Pharmacogenomics Reporter this week. "I'm not partial to any of these tests — that's one that seems to be useful," he said. "We would like to see more of those, and review the performance of these, because this is very early in the game, and we're thinking that this might be setting a trend for seeing more of these," he added.
Genomic Health declined to comment for this article.
In the "Best of Oncology" study, entitled "Expression of the 21 genes in the Recurrence Score Assay and Prediction of Clinical Benefit from Tamoxifen in [National Surgical Adjuvant Breast and Bowel Project] Study B-14 and Chemotherapy in NSABP study B-20," Soonmyung Paik, director of the NSABP division of pathology, showed that patients with large Oncotype Dx "recurrence scores" tend to have a greater absolute benefit from chemotherapy, according to a statement released by ASCO and Genomic Health.
In the B-20 portion of that study, which included 651 patients, Paik estimated that about 25 percent of patients with node-negative, estrogen receptor-positive breast cancer were likely to benefit from chemotherapy, as reflected by high recurrence scores. Patients with low scores represent about 50 percent of this group, and gain little from chemotherapy. The B-14 portion of the study, which studied 645 similar patients taking tamoxifen or placebo, found that the test score incorporates prognosis and the response to hormonal treatment, the statement said.
A second ASCO study, conducted by Northern California Kaiser Permanente, presented data showing a "strong and graded association" between the recurrence score and 10-year breast-cancer mortality, the NSABP and Genomic Health said.
A final study presented at ASCO, and published in the American Journal of Managed Care, presents an economic analysis showing evidence that Oncotype Dx can reduce treatment costs and improve "net medical outcomes," when adjusted for the detrimental impact of chemotherapy, the organizations said.
— Chris Womack ([email protected])