As part of an effort to ease the processes around pediatric cancer drug development, the FDA and European Medicines Agency on Wednesday unveiled a new template to provide companies with an easier way to seek scientific advice from both agencies.
The FDA and EMA have more closely aligned their timelines for the required submissions of plans for pediatric development of new cancer drugs, which has opened up an opportunity for sponsors to seek preliminary scientific advice from both regulators simultaneously.
The push comes as cancer remains the leading cause of death from disease in children, even despite advances that have pushed the 5-year survival rate to about 85%, officials from both the FDA and EMA wrote in an article published in the Journal of Clinical Oncology last September.
Despite some progress, there’s still a considerable lag between when a new cancer drug is used in adult trials and when it can be used for children.
“From 1997 to 2017, the median time from first-in-human studies of new cancer drugs ultimately approved by the US Food and Drug Administration (FDA) to ‘first-in-child studies’ reportedly was 6.5 years,” EMA and FDA officials wrote.
To try to plug that gap, the agencies are working together because in many cases, the scientific rationale for the earliest required studies included in the FDA’s initial pediatric study plans (iPSPs) and the EMA’s pediatric investigation plans (PIPs) and the justifications for full or partial waivers of those pediatric studies are expected to be similar or even identical.
Now, the two agencies are offering a side-by-side template outlining the common issues requested for discussion by the EMA and FDA with regard to iPSPs and PIPs, with sections explaining non-clinical and clinical studies, quality development, and timelines.
Both agencies call on sponsors of cancer drugs to begin pediatric studies without delay, although both agencies also explain circumstances when delays in child trials may be necessary to ensure sufficient adult data has been established.
“Given the global nature of cancer drug development and the relative rarity of childhood cancer, which impacts study populations for clinical trials, the demand for international collaboration in study design and conduct has intensified,” the FDA said in a statement. “We have recommended that new PIPs and iPSPs for new cancer products be submitted to their respective agencies simultaneously to promote global coordination and international research collaboration.”