The FDA has granted a priority review to a new drug application (NDA) for oral paclitaxel and encequidar (oral paclitaxel) for use in patients with metastatic breast cancer, according to an announcement from Athenex, Inc.1 The application was based on findings from a single pivota...
Inc. (Nasdaq: ATNX) that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer and has granted the application Priority Review. The FDA...
Speaking on a conference call, CEO Johnson Lau said the company was “surprised and extremely disappointed” by the FDA’s rejection. The neutropenia concerns cited are a known risk of paclitaxel, he said. Lau added that the review remained blinded, was conducted by independent radiologists, and...
2020. https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases Date AA, Hanes J, Ensign LM. Nanoparticles for oral delivery: Design, evaluation and state-of-the-art. J Control Release. Elsevier B.V.; 2016;240:504–26. Holmgren J, Czerkinsky C. Mucosal ...
Paclitaxel-loaded TPGS- b -pcl nanoparticles: in vitro cytotoxicity and cellular uptake in MCF-7 and MDA-MB-231 cells versus mPEG- b -pcl nanoparticles and abraxane ® J. Nanosci. Nanotechnol., 16 (2016), pp. 160-170, 10.1166/jnn.2016.10739 View in ScopusGoogle Scholar ...
Ethical Approval “This article does not contain any studies with human participants performed by any of the authors.”“This article does not contain any studies with animals performed by any of the authors.”“This article does not contain any studies with human participants or animals performed...
‘Encouraging’ DFS in BCG-Unresponsive NMIBC Iparomlimab/Tuvonralimab Plus Chemo ± Bevacizumab Yields Responses in Recurrent/Metastatic Cervical Cancer BMS-986253 Plus Nivolumab/Ipilimumab Fails to Boost Responses in Advanced Melanoma After Prior Anti–PD-(L)1 Therapy Tremelimumab Plus Paclitaxel ...
Paclitaxel Paliperidone Palovarotene Pantoprazole Papaverine Parecoxib Paritaprevir Paroxetine Pasireotide Pemigatinib Pentamidine Pentazocine Perphenazine Pexidartinib Phenindione Phenobarbital Phenprocoumon Phenytoin Pipamperone Pirmenol Piroxicam Ponesimod Posaconazole Prajmaline Pralsetinib Primidone Probucol Procaina...
Paclitaxel is probably most well known for its semisynthetic method of production and the novel mechanism of anticancer activity, i.e., β tubulin binding and microtubule stabilization that prevents G2-M cell progression (Cragg, 1998) (Figure 7). It is administered intravenously, but suffers from...
There are a lot of private practices that are in OCM, and I’m confident that if they’ve got a generic paclitaxel IV compared with a drug that might cost $10,000 a month, they’re going to work very hard to try to get that patient to tolerate the IV paclitaxel....