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Opaxio Approval Status

FDA Approved: No
Brand name: Opaxio
Generic name: paclitaxel poliglumex
Previous Name: Xyotax
Company: Cell Therapeutics, Inc.
Treatment for: Non-Small Cell Lung Cancer, Ovarian Cancer, Glioblastoma Multiforme, Head and Neck Cancer

Opaxio (paclitaxel poliglumex) is an investigational, biologically enhanced form of the chemotherapeutic agent paclitaxel in development for the treatment of various forms of cancer.

Development Status and FDA Approval Process for Opaxio

DateArticle
Jan 28, 2014Cell Therapeutics Announces GOG Completes Patient Enrollment in GOG-0212 Phase 3 Clinical Trial of Paclitaxel Poliglumex (Opaxio™) as Maintenance Therapy in Ovarian Cancer
Feb 24, 2011High Rates of Pathological Complete Response in Patients with Advanced Esophageal Cancer in OPAXIO Phase II Study Reported in American Journal of Clinical Oncology
Nov 22, 2010Paclitaxel Poliglumex (OPAXIO) Combined with Temozolomide and Radiotherapy Demonstrates High Response Rates with Encouraging Progression Free Survival in Malignant Brain Cancer
Jun  7, 2010OPAXIO Phase II Study Results Confirm High Rate of Complete Response with Low Rate of Side Effects in Patients with Advanced Esophageal Cancer
Oct  3, 2009OPAXIO Produces High Rates of Pathologic Complete Remission in Patients with Advanced Esophageal Cancer; Study Paves Way for Potential Registration Trial as Radiation Sensitizer
Aug  6, 2009Opaxio Combined with Alimta Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer
Jun  5, 2009Paclitaxel Poliglumex (OPAXIO Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer
Jun  3, 2008Paclitaxel Poliglumex (Opaxio)/Capecitabine Regimen Well Toleratedand Active in Metastatic Breast Cancer
Apr 17, 2007Lung Cancer Alliance Hails FDA Decision to Expedite Review of Xyotax Treatment for Lung Cancer
Jun  1, 2006CTI and FDA Agree on NDA Filing Strategy for Xyotax
Aug 24, 2005CTI Plans to Submit Marketing Applications for Xyotax

Further information

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