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Panel votes against IntraDose

September 10, 2001 7:00 AM UTC

The FDA's Oncologic Drugs Advisory Committee on Monday voted 13-0 that trial data did not provide substantial evidence that IntraDose cisplatin/epinephrine injectable gel from Matrix (MATX) is safe and effective in the treatment of symptomatic recurrent head and neck cancer (see BioCentury Extra, Friday Sep. 7). Central to the vote was the issue of patient benefit, a co-primary endpoint in MATX's two Phase III studies. The trials did show significance on tumor response (the other co-primary endpoint), but FDA statistician Rajeshwari Sridhara noted at the meeting that "both studies failed to show patient benefit by sponsor and FDA analysis. Tumor response did not equate to benefit." FDA reviewer Gregory Frykman said the agency wanted to see a strong correlation between clinical benefit and objective response.

Some panel members, however, noted that measuring clinical benefit in MATX's patient population is extremely difficult. "Biologically, something is going on here with IntraDose," said panel member Bruce Redman, associate professor of internal medicine at the University of Michigan Comprehensive Cancer Center (Ann Arbor, Mich.). "But aside from tumor shrinkage, I don't know how to measure what's happening." ODAC's John Carpenter, professor of medicine at the University of Alabama (Birmingham, Ala.) added that "there's a small but definite response rate, but we don't know how to get at clinical benefit." ...