Full Press Release Details
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.
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.