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Submits Marketing Authorisation Application via Project Orbis for Eflornithine (difluoromethylornithine [DFMO]) in High-risk Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Eflornithine
Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
CPP-1X-T (eflornithine) is a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes. It is approved by USFDA for the treatment of Pediatric Neuroblastoma.
Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
DFMO (eflornithine) is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, which is investigated in combination with eflornithine in patients newly diagnosed with glioblastoma.
Panbela has divested certain assets in its eflornithine pediatric neuroblastoma program including, CPP-1X (eflornithine), being developed for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes.
The agreement is for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial is evaluating the maximum tolerated dose of CPP-1X (eflornithine).
CPP-1X-T (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes.
Panbela has regained the North American rights to develop and commercialize Flynpovi (the combination of CPP-1X (eflornithine hydrochloride) and sulindac) in patients with FAP. The drug is withdrawn form the european market and company will conduct FAP trial for phase 3.
The collaboration is intended to expand the development of Panbela’s investigative agent SBP-101 (ivospemin), including activity in models of ovarian and other cancer types, further evaluations into MOA, and potential combination with CPP-1X and standard of care agents.