Cell Therapeutics, Inc. said it intends to utilize the results of the phase III first-line indolent trial of Zevalin (ibritumomab tiuxetan), known as the FIT trial, for submission to the United States Food and Drug Administration (FDA) for potential approval in the consolidation of first remissions following chemotherapy for patients with follicular non-Hodgkin's lymphoma (NHL).
CTI has signed an agreement to acquire the US marketing, sales and development rights to Zevalin, however, that acquisition has not yet been completed and remains subject to closing conditions, including obtaining certain third party consents, and until the transaction is closed, Zevalin remains a product and trademark of Biogen Idec, Inc. CTI expects the acquisition to close by the end of November. The results of the FIT trial will be presented at the 49th Annual Meeting of the American Society of Hematology (ASH), being held December 8-11, 2007 in Atlanta.
Bayer Schering recently announced it had submitted the FIT results to the EMEA for consideration for a new indication for the product in the European Union (EU).
"With our commercial leadership now on board we look forward to the prospects of working closely with Bayer-Schering in providing the support for the Zevalin brand that this important therapeutic deserves," said James A. Bianco, M.D., president and CEO, CTI.
Zevalin (Ibritumomab Tiuxetan) is a form of cancer therapy called radio immunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radio immunotherapeutic agent for the treatment of NHL.
Deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anaemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukaemia was observed in 2 per cent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Pixantrone (BBR 2778) is an investigational agent under development for the potential treatment of various haematological malignancies, solid tumours and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumour types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to currently marketed anthracyclines.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.