On April 23, 2024, Day One’s OJEMDA™ (tovorafenib) received U.S. Food and Drug Administration (FDA) Accelerated Approval for patients 6 months of age and older for the treatment of relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
FDA approval of OJEMDA means that OJEMDA is now available for prescription by health care professionals in the United States.
The approval of OJEMDA ushers in a new day for children living with pLGG, and we are pleased that we can deliver the first and only targeted medicine for both BRAF fusions and mutations, for children living with relapsed or refractory pLGG, the most common form of pediatric brain cancer,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “We are grateful to the pLGG community, including patients and their families, clinicians, and advocacy groups, for their collaboration and support as we close the innovation gap for children with cancer waiting for new treatments.
To support the patient community, we are pleased to announce EveryDay Support From Day One™, a comprehensive program that offers personalized services for OJEMDA patients and their care teams. We are offering a variety of services and financial assistance programs to help eligible patients with coverage and affordability. EveryDay Support From Day One can help patients manage the process, from initiating and maintaining coverage, to helping with affordability throughout the patient’s treatment journey. Services include shipping medication to patients’ homes, and ongoing prescription and refill support. Caregivers and healthcare providers can visit www.everydaysupport.com for more information.
For more details, the complete press release is available here.
On behalf of everyone at Day One, we thank the patients for their participation in the FIREFLY-1 trial and their families, without whom this advancement of a new approved targeted therapy for pLGG would not be possible. We also thank the pediatric cancer non-profit and patient advocacy community for your partnership and support as we move forward in developing potential new therapies for children with cancer.
INDICATION
What is OJEMDA™ (tovorafenib)?
OJEMDA is a prescription medicine used to treat certain types of brain tumors (cancers) called gliomas in patients 6 months and older:
IMPORTANT SAFETY INFORMATION
Before taking or giving OJEMDA, tell your healthcare provider about all of your or your child’s medical conditions, including if you:
Females who are able to become pregnant:
Males with female partners who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment with OJEMDA and for 2 weeks after your last dose of OJEMDA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while taking OJEMDA?
Limit the amount of time you spend in sunlight. OJEMDA can make your skin sensitive to the sun (photosensitivity). Use sun protection measures, such as sunscreen, sunglasses and wear protective clothes that cover your skin during your treatment with OJEMDA.
What are the possible side effects of OJEMDA?
OJEMDA may cause serious side effects, including:
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The most common side effects of OJEMDA include:
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OJEMDA may cause fertility problems in males and females, which may affect your ability to have children.
These are not all the possible side effects of OJEMDA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Product Information and Instructions for Use for more information.
On October 30, 2023, Day One announced that the U.S., Food and Drug Administration (FDA) accepted Day One’s New Drug Application (NDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The NDA is based on results from FIREFLY-1, the open-label, pivotal Phase 2 trial evaluating tovorafenib as a once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pLGG.
FDA acceptance of the NDA means that the FDA will now review the application for potential approval of tovorafenib for sale and marketing in the U.S.
Additionally, with Day One’s NDA, the FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
Tovorafenib is an investigational medicine. The safety and efficacy of tovorafenib has not been established. There is no guarantee that tovorafenib will receive health authority approval or become commercially available in any country for the uses being investigated.
For more details, the complete press release is available here.
On behalf of everyone at Day One, we thank the patients for their participation in the FIREFLY-1 study and their families, without whom this advancement toward a potential new targeted therapy for pLGG would not be possible.
We also thank the pediatric cancer non-profit and patient advocacy community for your partnership and support as we move forward in developing potential new therapies for children with cancer.
On September 11, 2023, Day One announced the submission of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). We anticipate the FDA will determine the acceptability of the rolling NDA submission by mid-November 2023.
For more details, the complete press release is available here.
On June 4, 2023, Day One announced new data from the registrational Phase 2 FIREFLY-1 clinical trial. These data were shared in an oral presentation delivered by Dr. Lindsey Kilburn at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
In addition, Day One announced that it has initiated a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).
You can read the full press release here.
On April 26, 2023, Day One announced our accepted abstracts for the 2023 American Society of Clinical Oncology (ASCO) meeting in June.
For more information, please see our press release here.
On January 8, 2023, Day One announced top-line results from our ongoing pivotal Phase 2 FIREFLY-1 trial of tovorafenib (DAY101) in patients with recurrent or progressive pediatric low-grade glioma, or pLGG.
For more details, the complete press release is available here.
On June 12, 2022, Day One announced positive initial data from the first subset of participants in our ongoing pivotal Phase 2 FIREFLY-1 trial of tovorafenib (DAY101) in patients with relapsed pediatric low-grade glioma, or pLGG. Please see our press release and corporate presentation for more details.
For more details, the complete press release is available here.
