PixuvriTreatment for non-Hodgkin's Lymphoma
Pixantrone NDA Submission Completed
Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Completed NDA submission could lead to marketing approval in Q4-2009
SEATTLE, June 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has completed the submission of the 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 requested priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is currently available in Europe on a named-patient basis.
"This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business," said James A. Bianco, M.D., Chief Executive Officer of CTI. "With more than 76,000 pages and 500,000 hyperlinks this submission represents the hard work of many CTI employees dedicated to making a difference in the lives of patients with cancer. This also represents a significant advance in the treatment of patients with relapsed/refractory aggressive NHL, a patient population which the FDA has acknowledged represents an unmet medical need."
About the PIX 301 EXTEND Trial
CTI's EXTEND (PIX 301) clinical trial (the "PIX 301 EXTEND trial") was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population as selected by the physician.
CTI previously announced that its pivotal 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 out of 70 patients (20.0%) for the pixantrone arm compared to four out of 70 patients (5.7%) for the standard chemotherapy arm, p=0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to eight out of 70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (ORR) (26 out of 70 (37.1%) for the pixantrone arm compared to ten out of 70 (14.3%) for the control arm, p=0.003). Additionally, pixantrone experienced a statistically significant improvement in median progression-free survival (PFS), compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p=0.007, respectively). PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.
The most common grade 3/4 adverse event observed on the pixantrone arm was neutropenia in 41.2% of patients versus 19.4% on the comparator arm. However, the incidence of grade 3/4 febrile neutropenia was only 7.4% versus 3.0% in the comparator arm. Grade 3/4 infections had a similar incidence in both study arms (18% vs. 13%). Although the grade 3/4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a slightly higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (8.8% vs. 4.5%). Events considered cardiac disorders included cardiac arrest, congestive heart failure, myocardial infarction, cyanosis, pericardial effusion, and tachycardia.
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. 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. For additional information, please visit www.CellTherapeutics.com.
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, including whether CTI will become profitable and the development of pixantrone. 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, without limitation, the potential failure of pixantrone to prove safe and effective (including the failure to achieve the overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3/4 adverse events, including cardiac disorders) for the treatment of relapsed or refractory aggressive NHL as determined by the FDA, the potential that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in six months or in the fourth quarter of 2009, CTI'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 CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. 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
Source: Cell Therapeutics, Inc.
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Posted: June 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 Initiating Rolling NDA Submission For Pixantrone - April 14, 2009
Pixuvri (pixantrone) FDA Approval History