Epothilone

73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) from Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis

Retrieved on: 
Friday, March 29, 2024
ODD, Lung cancer, HER2, Epothilone, Survival, Prognosis, Brain, BBB, Central nervous system, Synthetic biology, Patient, SAN, CNS, Etoposide, Triple-negative breast cancer, Glioma, Traffic barrier, CBR, Bevacizumab, Breast cancer, PFS, FDA, TNBC

As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].

Key Points: 
  • As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].
  • Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux.
  • The FDA granted ODD to utidelone injectable for the treatment of BCBM based on these promising data.
  • Considering utidelone's excellent BBB-crossing capability and its therapeutic potential for brain tumors, Biostar Pharma also plans to advance the clinical studies of utidelone injectable for the treatments of other brain tumors such as lung cancer brain metastasis and glioma this year.

AlgoTx’s ATX01 Granted Fast Track Designation by FDA for Chemotherapy-Induced Neuropathic Pain

Retrieved on: 
Thursday, June 9, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Epothilone, CIPN, Amitriptyline, Food, Toxicity, CEO, Erythromelalgia, Pain, ODD, IND, Multimedia, FDA, Patient, Chemotherapy-induced peripheral neuropathy, Fast Track, Review, Nerve, Quality of life, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, EU

AlgoTx announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA), for the development of ATX01 in chemotherapy-induced neuropathic pain.

Key Points: 
  • AlgoTx announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA), for the development of ATX01 in chemotherapy-induced neuropathic pain.
  • Chemotherapy-induced neuropathic pain is a debilitating condition caused by neurotoxic cancer agents such as platinum derivatives, taxanes, epothilones, plant alkaloids and other drugs.
  • Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.
  • AlgoTx is a European biotech founded in 2018 to develop innovative solutions for complex pain, with initial programs focusing on chemotherapy-induced neuropathic pain and erythromelalgia (US and EU ODD granted).