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
|Jan 28, 2014||Cell 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, 2011||High 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, 2010||Paclitaxel Poliglumex (OPAXIO) Combined with Temozolomide and Radiotherapy Demonstrates High Response Rates with Encouraging Progression Free Survival in Malignant Brain Cancer|
|Jun 7, 2010||OPAXIO Phase II Study Results Confirm High Rate of Complete Response with Low Rate of Side Effects in Patients with Advanced Esophageal Cancer|
|Oct 3, 2009||OPAXIO 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, 2009||Opaxio Combined with Alimta Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer|
|Jun 5, 2009||Paclitaxel Poliglumex (OPAXIO Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer|
|Jun 3, 2008||Paclitaxel Poliglumex (Opaxio)/Capecitabine Regimen Well Toleratedand Active in Metastatic Breast Cancer|
|Apr 17, 2007||Lung Cancer Alliance Hails FDA Decision to Expedite Review of Xyotax Treatment for Lung Cancer|
|Jun 1, 2006||CTI and FDA Agree on NDA Filing Strategy for Xyotax |
|Aug 24, 2005||CTI Plans to Submit Marketing Applications for Xyotax |
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