MarqiboTreatment for Acute Lymphoblastic Leukemia
Update: Marqibo (vincristine sulfate liposome injection) Now FDA Approved - August 9, 2012
INEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo
VANCOUVER, British Columbia and BRIDGEWATER, N.J., December 1, 2004 -- Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon Pharmaceuticals Inc. ("ENZON"; NASDAQ: ENZN) announced today that the Oncology Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA) voted unanimously against recommending accelerated approval for Marqibo (vincristine sulfate liposomes injection) as a treatment for patients with relapsed aggressive non- Hodgkin's lymphoma (NHL).
Based on this outcome, the companies believe the FDA will not grant accelerated approval for Marqibo. The FDA's decision on the New Drug Application (NDA) is expected by January 15, 2005.
"We are disappointed with the ODAC panel vote," said David Main, President and CEO of INEX. "We will take the FDA's full review into consideration to chart a new course to approval for Marqibo."
Kenneth J. Zuerblis, Executive Vice President and CFO of ENZON said, "We will work with INEX to determine the appropriate next steps for Marqibo."
About Marqibo (vincristine sulfate liposomes injection)
Marqibo is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX's sphingosomal drug delivery technology. INEX's technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness and reduce the side effects of the encapsulated drug. In May 2004, the FDA accepted a New Drug Application (NDA) seeking marketing approval of Marqibo as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma previously treated with at least two combination chemotherapy regimens.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the sixth-leading cause of cancer deaths in the United States (19,400 estimated in 2004) and the fifth-leading cause of cancer deaths in Canada (2,900 estimated in 2004), according to estimates of the American Cancer Society and the Canadian Cancer Society. An estimated 54,370 and 6,200 new cases will be diagnosed in the US and Canada respectively in 2004.
The Oncologic Drugs Advisory Committee (ODAC) is a committee formed by the FDA of external experts to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer. The Committee is comprised of a core of thirteen voting members from the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics and other related professions.
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
Posted: December 2004
- FDA Approves Marqibo for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia - August 9, 2012
- Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo - May 7, 2012
- Tekmira Provides Update on Licensed Product Candidate, Marqibo - April 2, 2012
- FDA Issues Not Approvable Letter for Marqibo - January 19, 2005
- INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee - September 27, 2004