Ipsen And Day One Enter Ex-U.S. Licensing Deal For Pediatric Brain Cancer Drug Tovorafenib
Ipsen And Day One Enter Ex-U.S. Licensing Deal For Pediatric Brain Cancer Drug Tovorafenib
艾普生和第一天注入进入儿童脑癌药物托伏拉芬布的美国以外授权交易。
- Ipsen secures ex-U.S. regulatory and commercial rights to tovorafenib for most common childhood brain tumor, pediatric low-grade glioma (pLGG), and any future indications
- OJEMDA (tovorafenib) is the first FDA-approved treatment for relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or V600 mutation, following the pivotal Phase II trial, FIREFLY-1
- Day One receives approximately $111 million upfront in cash and equity investment with up to approximately $350 million in milestone payments and double-digit tiered royalties
- Ongoing Phase III trial, FIREFLY-2, is evaluating tovorafenib as a monotherapy for newly diagnosed children and young adults with RAF-altered low-grade glioma requiring first-line systemic therapy
- Ipsen获得了Tovorafenib在除美国外地区关于大多数常见的儿童脑肿瘤、儿童低级别胶质瘤（pLGG）以及未来的任何适应症的监管和商业权利。
- OJEMDA（Tovorafenib）是第一款经FDA批准用于携带BRAF融合或重排，或V600突变的复发性或难治性pLGG的治疗，经过了关键的2期FIREFLY-1试验。
- Day One将获得大约1.11亿美元的现金和股票投资以及高达大约3.5亿美元的里程碑付款和两位数的分层版税。
- 进行中的3期FIREFLY-2试验评估Tovorafenib作为新诊断携带RAF改变低级别胶质瘤且需要首线全身治疗的儿童和年轻成人的单药治疗。
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