Children wait six and half years longer than adults for new cancer drugs, study says
pharmafile | May 22, 2019 | News story | Research and Development | Cancer, FDA, children, oncology, paediatrics, pharma
Children wait six and half years longer than adults to access new cancer drugs, according to a study from Dana-Farber/Boston Children’s Cancer and Blood Disorders Center.
Cancer drugs approved by the FDA took on average 6.5 years to go from first clinical trial in adults to first clinical trial in children, the study says.
“Despite knowing that these agents are effective anticancer drugs, it’s taking too long to even start studying these therapies in children,” study author, Dr Steven DuBois said.
“As a doctor taking care of young cancer patients, this is tremendously frustrating. If I were a parent of a child with cancer, I wouldn’t stand for this.”
The study, published in the European Journal of Cancer, looked at trials of cancer drugs between 1997 and 2017.
In that time 126 drugs received FDA approval for an oncology indication. After excluding hormonal modulators, which are not used in children, 117 drugs were analysed.
Of the 117 drugs analysed, 15 (12.8%) had not yet been trialled in children. Just six (5.1%) of the 117 drugs included children in the initial FDA approval.
“Some may argue that this lag is appropriate to ensure safety of a vulnerable paediatric population and to only study agents in children that are on a path to FDA approval, based upon activity in adults with cancer,” says DuBois.
“Others may argue that this lag is too long for children with life-threatening diseases and that some agents that fail in adult indications may nevertheless prove to be important drugs for paediatric indications.”
Louis Goss
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