Pixuvri FDA Approval Status
FDA Approved: No
Brand name: Pixuvri
Generic name: pixantrone
Company: Cell Therapeutics, Inc.
Treatment for: Non-Hodgkin's Lymphoma
Pixuvri (pixantrone) is a novel major groove binder with an aza-anthracenedione molecular structure in development to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
Development timeline for Pixuvri
| Date | Article |
|---|
| Jul 9, 2018 | Results of Phase III (PIX306) Trial Evaluating Progression-Free Survival of Pixuvri (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma |
| Jan 30, 2012 | Cell Therapeutics Withdraws New Drug Application for Pixuvri and Plans to Resubmit in 2012 |
| Jan 3, 2012 | FDA's Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012 |
| Dec 6, 2011 | FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application |
| Oct 25, 2011 | Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval |
| Jun 14, 2011 | Cell Therapeutics Completes Type A Meeting With FDA's Division of Oncology Drug Products: Guidance Provided for Resubmission of Pixantrone NDA for Consideration of Accelerated Approval |
| May 20, 2011 | FDA Sets Meeting Date in Early June to Discuss Re-submission of Pixantrone NDA for Accelerated Approval |
| May 3, 2011 | Cell Therapeutics to Re-submit Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDA's Office of New Drugs |
| Dec 3, 2010 | Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma |
| Sep 14, 2010 | Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma |
| Apr 9, 2010 | CTI Receives Complete Response Letter from the FDA for Pixantrone NDA; CTI to File for Expanded Access for Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma |
| Mar 22, 2010 | CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma |
| Mar 2, 2010 | FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone |
| Feb 9, 2010 | FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions |
| Dec 17, 2009 | Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010 |
| Sep 6, 2009 | FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA |
| Aug 26, 2009 | FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone |
| Jun 24, 2009 | Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review |
| Apr 14, 2009 | Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone |
Further information
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