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Approving Children's Cancer Drugs Takes 6.5 Years Longer

WEDNESDAY, June 12, 2019 -- For cancer drugs ultimately approved by the U.S. Food and Drug Administration, the median lag time from first-in-human to first-in-child trials is 6.5 years, according to a study published in the May issue of the European Journal of Cancer.

Dylan V. Neel, from Harvard University in Boston, and colleagues conducted a systematic analysis of time from first-in-human trials to first-in-child trials (age of eligibility <18 years) of agents first approved by the FDA for any oncology indication from 1997 to 2017.

The researchers found that during the study period, 126 drugs were initially approved for an oncology indication. Of these, 117 were nonhormonal drugs used in further analyses. Only 5.1 percent (six drugs) had an initial approval that included children, while 12.8 percent (15 drugs) still did not have a pediatric trial. There was a median time of 6.5 years between the first-in-human trial and first-in-child trial (range 0 to 27.7 years). From initial FDA approval to the first-in-child clinical trial, the median time was −0.66 years (range −43 to +19 years). Findings were similar regardless of year of initial FDA approval, drug class, or initial approved disease indication.

"These results provide a benchmark against which to evaluate recent initiatives designed to hasten drug development relevant to children with cancer," the authors write.

One researcher disclosed financial ties to the pharmaceutical industry.

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Posted: June 2019

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