Name: Tovorafenib (DAY101) in RAF-altered pediatric low-grade glioma requiring first-line systemic therapy: Ongoing post-approval monitoring
Published: 2026-09-17T18:16:08-04:00

Product information and disease description Place of product in therapy Approaches to treatment

Ongoing post-approval monitoring

5 evidence topics · 4 sources

United States: periodic reporting on the confirmatory trial

“You must submit status reports of the progress of each clinical trial required under section 506(c) (listed above) to the NDA 180 days after the date of approval of this NDA and approximately every 180 days thereafter (see section 506B(a)(2) of the FDCA) (hereinafter “180-day reports”).” (opens the source at this quote in a new tab)

United States: enhanced pharmacovigilance for wrong-dose medication errors

“We request that you submit all U.S. cases that describe a wrong dose error or potential for a wrong dose error involving Ojemda, as 15-day Alert reports (as described under 21 CFR 314.80(c)(1)), for a period of 3 years following the U.S. approval date.” (opens the source at this quote in a new tab)

European Union: additional monitoring, periodic safety reports, and annual review

“This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.” (opens the source at this quote in a new tab)
“the marketing authorisation holder (MAH) shall submit PSURs every 6 months.” (opens the source at this quote in a new tab)

“Every year, the Agency will review any new information that becomes available.” (opens the source at this quote in a new tab)

European Union: risk management plan safety concerns

Category	Safety concern
Important identified risks	“Growth retardation”
Important identified risks	“Intratumoral haemorrhage”
Important potential risks	“Decreased fertility risk”
Missing information	“Long-term safety”

European Union: long-term safety follow-up through FIREFLY-2

“Further long-term safety data will be generated from the ongoing phase III study FIREFLY-2, agreed as an SOB under the conditional marketing authorisation. This study will follow patients for up to 5 years.” (opens the source at this quote in a new tab)
“No additional pharmacovigilance activities are required. This is agreed.” (opens the source at this quote in a new tab)