OJEMDA™ (tovorafenib) Now Available from Onco360 for the Treatment of Patients Six Months of Age and Older with Relapsed or Refractory Pediatric Low-Grade Glioma (LGG) Harboring a BRAF Fusion or Rearrangement, or BRAF V600 Mutation
April 29 2024 - 7:30AM
Onco360®, the nation’s leading independent Specialty Pharmacy, has
been selected as a pharmacy partner by Day One Biopharmaceuticals
for OJEMDA™ (tovorafenib), which is now FDA approved for the
treatment of patients six months of age and older with relapsed or
refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion
or rearrangement, or BRAF V600 mutation. This indication is
approved under accelerated approval based on response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s).
“Onco360 is grateful for the opportunity to partner with the
team at Day One Biopharmaceuticals and become a specialty pharmacy
provider for OJEMDA,” said Benito Fernandez, Chief Commercial
Officer. “We are proud to add the first and only FDA-approved,
once-weekly oral medicine for children six months and older with
pediatric LGG that returned or did not respond to previous
treatment and who have a certain type of abnormal BRAF gene.”
Pediatric LGG is the most common central nervous system (CNS)
tumor diagnosed in children, representing approximately 30% of
pediatric brain tumors. BRAF is the most commonly altered gene in
pediatric LGG given that up to 75% of patients have BRAF
alterations. The five-year overall survival (OS) for pediatric LGG
is approximately 95%.1,2 The FDA approval for OJEMDA is based
on the ongoing multicenter, open-label, single-arm FIREFLY-1
(NCT04775485) clinical trial. Eligible patients were required to
have a relapsed or refractory pediatric LGG harboring an activating
BRAF alteration based on local laboratory testing. All patients
received at least one line of prior systemic therapy and documented
evidence of radiographic progression. OJEMDA administration
resulted in a 51% overall response rate (ORR) in the aforementioned
FIREFLY-1 population including 76 patients. The most common adverse
reactions (occurring in at least 30% of patients) were rash, hair
color changes, fatigue, viral infection, vomiting, headache,
hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis
acneiform, and upper respiratory tract infection.3
Please see the full Prescribing Information for OJEMDA.
About Onco360 Oncology Pharmacy:Onco360 is the
nation’s largest independent Oncology Pharmacy and clinical support
services company. Onco360 was founded in 2003 to bring together the
stakeholders involved in the cancer treatment process and serve the
specialized needs of oncologists, patients, hospitals, cancer
centers of excellence, manufacturers, health plans, and payers. It
dispenses nationally through its network of URAC-, and
ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in
Louisville, Kentucky, and is a flagship specialty pharmacy brand of
PharMerica Corporation, a leading institutional pharmacy, specialty
infusion, and hospital services company servicing healthcare
facilities in the United States. For more information about
Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief
Commercial OfficerBenito.Fernandez@Onco360.com516-640-1332
References:
1) |
|
Ryall, S., Tabori, U. & Hawkins, C. Pediatric low-grade glioma
in the era of molecular diagnostics. Acta Neuropathol.
Commun. 8, 30 (2020). |
2) |
|
Stokland T et al. A multivariate analysis of factors determining
tumor progression in childhood low-grade glioma: A population-based
cohort study (CCLG CNS9702). Neuro Oncol 12:1257-1268, 2010. |
3) |
|
OJEMDA Prescribing Information. Brisbane, CA: Day One
Biopharmaceuticals, INC; April 2024. |