Pediatric Cancer: US FDA May Invite European Regulators To Observe ‘Type F’ Meetings With Sponsors
Early advice meetings allow sponsors to hear the FDA’s current thinking about relevance of a specific molecular target and expectations for early assessment of an adult cancer drug in children unless a waiver or deferral is justified; agency has waived subsequent pediatric studies for some same-in-class products, including PD-1/L1 inhibitors.
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Initial draft list of molecular target candidates has industry, investigators and patient advocates asking how the agency intends to prioritize targets and same-in-class molecules for pediatric studies, and how frequently it will update the list; industry representatives divided as to whether ‘broader is better’ when it comes to the target list.
User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.
Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.