PixuvriTreatment for non-Hodgkin's Lymphoma
Rolling NDA Submission For Pixantrone
Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone
SEATTLE, April 14, 2009 — Cell Therapeutics, Inc. (CTI) announced today that it began a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission this quarter and will request priority review which if granted could lead to an approval decision from the FDA in Q4 2009.
"This is a significant milestone for CTI as we move pixantrone closer to addressing a truly significant unmet medical need for relapsed or refractory aggressive NHL patients," said James A. Bianco, M.D., CEO of CTI. "The commercialization of pixantrone will drive shareholder value as a result of the large market potential for this product. We believe that the recent significant investment in CTI by a single institutional investor reflects a growing interest in CTI and in particular in pixantrone by the investment community. With added financial resources, CTI can advance pixantrone through the NDA review process while we continue our progress on strategic business development opportunities and relationships."
CTI previously announced that its pivotal phase III (PIX 301) EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission. Additionally, progression-free survival (PFS) results from this study show patients treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p < 0.01, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. Pixantrone treatment also significantly increased the overall response rate (CR/CRu+PR) (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003).
Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea.
Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (5 vs. 2) with only 1 considered related to the study drug by the investigator. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).
The pixantrone study received Special Protocol Assessment approval from the FDA in 2004, and pixantrone has received fast track designation for this indication. The FDA's fast track programs are intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the FDA as they become available, allowing the review process to begin before the complete dossier has been submitted.
Pixantrone (BBR 2778), is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anti-cancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the NDA submission will not be completed in the second quarter of 2009, that priority review is not granted and that a decision by the FDA is not rendered in late 2009, the Company will be able to complete strategic partnerships, the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Lindsey Jesch Logan
Posted: April 2009
- Cell Therapeutics Withdraws New Drug Application for Pixuvri and Plans to Resubmit in 2012 - January 30, 2012
- FDA's Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012 - January 3, 2012
- FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application - December 6, 2011
- Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval - October 25, 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 - June 14, 2011
- FDA Sets Meeting Date in Early June to Discuss Re-submission of Pixantrone NDA for Accelerated Approval - May 20, 2011
- Cell Therapeutics to Re-submit Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDA's Office of New Drugs - May 3, 2011
- Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma - December 3, 2010
- Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma - September 14, 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 - April 9, 2010
- CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma - March 22, 2010
- FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone - March 2, 2010
- FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions - February 9, 2010
- 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 - December 17, 2009
- FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA - September 6, 2009
- FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone - August 26, 2009
- Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review - June 24, 2009