Tovorafenib is under clinical development by Day One Biopharmaceuticals and currently in Phase II for Melanoma. According to GlobalData, Phase II drugs for Melanoma have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Tovorafenib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tovorafenib overview

Tovorafenib (Ojemda) acts as an antineoplastic agent. It is formulated as tablets and suspension for oral route of administration. Ojemda is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric lowgrade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

Tovorafenib (TAK-580 (MLN2480)) is under development for the treatment of solid tumors such as glioma, melanoma, relapsed pediatric low-grade glioma, Langerhans-cell histiocytosis, craniopharyngioma and malignant glioma. It is administered through oral route. The drug candidate acts by targeting pan-Raf kinases A-Raf, B-Raf and C-Raf. It was also under development for the treatment of solid tumors like metastatic melanoma and non-small cell lung cancer.

Day One Biopharmaceuticals overview

Day One Biopharmaceuticals is a biopharmaceutical company. It discovers and develops drugs for addressing the unmet medical needs of cancers associated with genetic mutations in rapidly accelerated fibrosarcoma (RAF) family kinases. The company investigates its lead product candidate: DAY101 (TAK-580), a pan-RAF inhibitor for the treatment of low-grade glioma and cancers that foster genetic alterations in RAF. It works in partnership with research and the parent advocacy communities to advance the development of medicines for the treatment of various cancer types. Day One Biopharmaceuticals is headquartered in Brisbane, California, the US.

For a complete picture of Tovorafenib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.