rubitecan
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Orathecin | pancreatic ductal adenocarcinoma | 2006-01-20 | “today announced that it has withdrawn its Marketing Authorization Application (MAA) for Orathecin ™ (rubitecan) Capsules from the European Medicines Agency (EMEA).” astx.com ↗ |
| Withdrawn | US (FDA) | Orathecin | pancreatic ductal adenocarcinoma | 2005-01-03 | “today announced that it has withdrawn its New Drug Application (NDA) for Orathecin ™ (rubitecan) Capsules” astx.com ↗ |
| Filed | EU (EMA) | Orathecin | pancreatic ductal adenocarcinoma | 2004-07-02 | “a Marketing Authorization Application (MAA) seeking approval of Orathecin ™ (rubitecan) Capsules has been submitted to the European Agency” astx.com ↗ |
| Filed | US (FDA) | Orathecin | pancreatic ductal adenocarcinoma | 2004-01-27 | “completed submission to the FDA of a rolling New Drug Application (NDA) for the investigational anticancer compound Orathecin ™ (rubitecan) capsules.” astx.com ↗ |
Trials 20
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2006-04-26 | Astex Pharmaceuticals, Inc. | Results SuperGen Announces Interim Results of Orathecin™ Combination Trial in Pancreatic Cancer astx.com ↗
The analysis result is an estimated median survival of 6.0 months, with a Kaplan -Meier one year survival to be 27%. |
| 2006-01-20 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Announces Withdrawal of Orathecin™ Marketing Authorization Application astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) today announced that it has withdrawn its Marketing Authorization Application (MAA) for Orathecin ™ (rubitecan) Capsules from the European Medicines Agency (EMEA). |
| 2005-05-16 | Astex Pharmaceuticals, Inc. | Results SuperGen Reports Results of Phase III Rescue Study With Orathecin™ (Rubitecan Capsules) Versus 5-FU in Pancreatic Cancer Patients astx.com ↗ |
| 2005-01-03 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Announces Withdrawal of Orathecin™ NDA astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) today announced that it has withdrawn its New Drug Application (NDA) for Orathecin ™ (rubitecan) Capsules based on feedback indicating that the current data package would not be sufficient to gain approval for Orathecin at this time in the United States. |
| 2004-11-29 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Announces 90 Day Extension of FDA Review Date for Orathecin™ New Drug Application astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) today announced that it received notification from the U.S. Food & Drug Administration (FDA) that the Agency extended the Pharmaceutical Drug User Fee Act (PDUFA) date for completing its review of the Orathecin ™ (rubitecan) capsules New Drug Application (NDA) to February 26, 2005. |
| 2004-07-02 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Submits Application for EMEA Approval of Orathecin™ astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) announced today that a Marketing Authorization Application (MAA) seeking approval of Orathecin ™ (rubitecan) Capsules has been submitted to the European Agency for the Evaluation of Medicinal Products (EMEA). |
| 2004-03-26 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen’s New Drug Application for Orathecin™ (rubitecan) Capsules Accepted by FDA for Filing astx.com ↗
SuperGen Inc. (Nasdaq: SUPG - ) announced today that the Food and Drug Administration (FDA) has officially accepted the Orathecin ™ (rubitecan) capsules' New Drug Application (NDA) for filing. |
| 2004-01-27 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Completes Submission of New Drug Application (NDA) for Orathecin™ As an Oral Treatment for Pancreatic Cancer astx.com ↗
SuperGen Inc. (Nasdaq: SUPG - ) announced today that it has completed submission to the FDA of a rolling New Drug Application (NDA) for the investigational anticancer compound Orathecin ™ (rubitecan) capsules. |
All press releases naming this drug 9 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rubitecan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00005826 ↗ |
| Known as | 9-NC | “The 9-nitrocamptothecin (9-NC) derivative to be used in this study is insoluble in water, but has demonstrated potent antitumor effects in mice and antitumor effect in humans.” NCT00249990 ↗3“Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer” NCT00006230 ↗ “Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme” NCT00005826 ↗ “A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma” NCT00005876 ↗ |
| Known as | 9-Nitro-20 (S)- Camptothecin | “The purposes of this study are: 1.1 To determine the efficacy of liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization to patients with metastatic...” NCT00249990 ↗ |
| Known as | 9-Nitro-Camptothecin | “Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme” NCT00005826 ↗4“Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer” NCT00006230 ↗ “A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma” NCT00005876 ↗ |
| Known as | L9NC | “The purposes of this study are:
1.1 To determine the efficacy of liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization to patients with metastatic...” NCT00249990 ↗2“Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)” NCT00250068 ↗ “L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin” NCT00250120 ↗ |
| Known as | Liposomal 9-Nitro-20 (S)-Camptothecin | “L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin” NCT00250120 ↗ |
| Known as | nitrocamptothecin | “PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have glioblastoma multiforme.” NCT00005826 ↗1“Arm I: Patients receive nitrocamptothecin orally on days 1-5.” NCT00005871 ↗ |
| Known as | Orathecin | “Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the...” NCT00113256 ↗ |
| Known as | RFS 2000 | “Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer” NCT00006230 ↗3“Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme” NCT00005826 ↗ “A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma” NCT00005876 ↗ “Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction” NCT00113113 ↗ |
| Action | Inhibit | “oral topoisomerase I inhibitor” NCT00006047 ↗ |
| Route | Oral | “Patients receive nitrocamptothecin orally daily on days 1-5.” NCT00005826 ↗ |