SynriboTreatment for Chronic Myelogenous Leukemia
Update: Synribo (omacetaxine) Now FDA Approved - October 26, 2012
ChemGenex Plans NDA Rolling Submission for Omacetaxine
ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (April 14, 2008). ChemGenex Pharmaceuticals today confirmed its intent to initiate a rolling New Drug Application (NDA) submission in support of omacetaxine mepesuccinate (formerly known as Ceflatonin) for the treatment of imatinib-resistant chronic myeloid leukemia (CML) patients with the T315I mutation in mid 2008. This decision follows a recent pre-NDA (New Drug Application) discussion with the U.S. Food and Drug Administration (FDA). It is currently anticipated that the rolling NDA submission will commence with the filing of the non-clinical section in mid 2008, followed by filings of the CMC (Chemistry and Manufacturing Controls) section and the clinical section in mid 2009.
The Fast Track designation granted for omacetaxine in November 2006 enables ChemGenex to file the NDA on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process.
"We are very pleased with the open and constructive discussion between ChemGenex and the FDA" said Dr. Greg Collier, ChemGenex’s Managing Director and Chief Executive Officer. "T315I+ positive CML is an unmet medical need, and we will continue an active dialog with the FDA as we work towards filing the NDA package.”
Supporting the confirmation of intended regulatory submission timing, ChemGenex is delighted to announce that Luana Staiger has joined the company as Vice President of Regulatory Affairs. Ms. Staiger will oversee the company's global regulatory development plans and be responsible for the company's regulatory submissions. Ms. Staiger has been working in the pharmaceutical and biotechnology industry for over 20 years, and has significant experience in regulatory affairs, quality assurance, and project management. Ms. Staiger’s experience in regulatory affairs management and product submissions with both the U.S. FDA and European regulatory authorities will be invaluable to the company over the coming year.
Ceflatonin is a registered trade-mark of ChemGenex Pharmaceuticals Limited.
About ChemGenex Pharmaceuticals Limited.
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing personalized oncology medicines. ChemGenex harnesses the power of genomics both to discover novel targets and drug compounds, and in clinical trials to develop more individualized treatment outcomes. ChemGenex’s lead compound, omacetaxine mepesuccinate (formerly known as Ceflatonin), is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML). ChemGenex has a second anticancer compound, amonafide dihydrochloride (formerly known as Quinamed) which is in phase 2 clinical development for various solid cancers, and a portfolio of assets in pre-clinical development. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP".
Posted: April 2008
- FDA Approves Synribo for Chronic Myelogenous Leukemia - October 26, 2012
- ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine - January 6, 2011
- ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro - October 5, 2010
- ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro - July 16, 2010
- ChemGenex Receives a Complete Response Letter from the FDA for Omapro - April 12, 2010
- U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of Omapro in Chronic Myeloid Leukemia Patients with T315I Mutation - March 24, 2010
- U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro - March 2, 2010
- Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010 - February 9, 2010
- ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation - December 17, 2009
- ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status - November 10, 2009
- ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA - September 9, 2009
- ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine - July 1, 2008