Evicenter
P&T meetings

Tovorafenib (DAY101)

RAF-altered pediatric low-grade glioma requiring first-line systemic therapy

Also known as TAK-580
Regulatory submission
Not announced
Launch
Not announced
Last updated
155 sources

Product information and disease descriptionProduct descriptionProduct information

Access and distribution

9 evidence topics · 12 sources

United States: specialty pharmacy distribution

“OJEMDA will be available in the U.S. through specialty pharmacy partners Biologics and Onco360.” (opens the source at this quote in a new tab)

“Tovorafenib is available only from a designated specialty pharmacy.” (opens the source at this quote in a new tab)

“Biologics and Onco360, will ship your patient’s medication to their home. They have pharmacists and nurses on staff who can help your patients with dosing and administration support.” (opens the source at this quote in a new tab)

United States: manufacturer patient support program

“As part of this commitment, we are pleased to announce EveryDay Support From Day One™, a comprehensive program that offers personalized services for eligible patients and their care teams, including insurance coverage support, financial assistance options, shipping medication to patients' homes, and educational resources.” (opens the source at this quote in a new tab)

United States: copay assistance and free drug program

“as little as $0 per month,” (opens the source at this quote in a new tab)

“and a program that may provide free medicine if you don’t have health insurance or are underinsured for OJEMDA.” (opens the source at this quote in a new tab)

“Restrictions and eligibility requirements apply. Not available for those with government insurance. Maximum benefit applies.” (opens the source at this quote in a new tab)

United States: manufacturer-reported coverage approval rate and time to receipt

“Health insurers approve OJEMDA for over 90% of prescribed patients with BRAF-altered pLGG, and on average, children prescribed OJEMDA receive it in as little as 2 weeks.” (opens the source at this quote in a new tab)

“Data as of June 2025, sourced from specialty pharmacy distribution partners who report all OJEMDA prescription approvals.” (opens the source at this quote in a new tab)

United States: payer prior authorization criteria limited to relapsed or refractory disease

“Ojemda may be considered medically necessary if the conditions indicated below are met.” (opens the source at this quote in a new tab)

“Ojemda may be considered investigational for all other indications.” (opens the source at this quote in a new tab)

“1. Relapsed or refractory pediatric low-grade glioma (LGG)” (opens the source at this quote in a new tab)

United States: biomarker testing requirement

“Information on FDA-approved tests for the detection of BRAF fusions, BRAF rearrangements, and BRAF V600 mutations is available at” (opens the source at this quote in a new tab)

United States: Risk Evaluation and Mitigation Strategy

“DRM and Division of Oncology 2 (D02) agree that a REMS is not necessary to ensure the benefits of tovorafenib outweigh its risks.” (opens the source at this quote in a new tab)

European Union: prescription status, Joint Clinical Assessment, and launch

“Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).” (opens the source at this quote in a new tab)

“The JCA report highlights the absence of a clearly established clinical comparator for much of the pLGG patient population, underscoring the significant unmet need in a setting with very limited approved treatments, as well as the challenges of generating comparative evidence in small, heterogeneous patient cohorts.” (opens the source at this quote in a new tab)

“We look forward to engaging with Member States and the pLGG community to facilitate timely reimbursement and access to this innovation for eligible patients.” (opens the source at this quote in a new tab)

“Ojemda: first sales, mainly related to specialized access schemes in Rest of World and launch in Germany.” (opens the source at this quote in a new tab)

Japan: companion diagnostic approval

“announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 17, 2026 for FoundationOne®CDx Cancer Genomic Profile to be used as a companion diagnostic for Ojemda® Tablets 100 mg and Ojemda Dry Syrup 300 mg (generic name: tovorafenib)” (opens the source at this quote in a new tab)

First-line pLGG: access outside clinical trials

No evidence found.

NCCN Guidelines listing

No evidence found.