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This estimate reflects several factors: (1) the continued integration of Bioenvision and the expanded introduction of Clolar in Europe; (2) investments in late-stage clinical trials-particularly the phase 3 study of alemtuzumab for multiple sclerosis; and (3) product launches, including the U.
Genzyme has requested a meeting with the FDA to discuss a path forward for the potential use of Clolar in adult patients with acute myeloid leukemia, following the receipt of a complete response letter regarding the company's sNDA this month.
The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.
The existing regimes and drugs market currently includes three regimens (Hyper-CVAD, Linker, and CALGB 8811) and three monotherapy drugs (Oncaspar, Clolar, and Arranon).
The historic growth in major markets such as the US, the top five countries of Europe and Japan were driven mainly by the increasing prevalence and prescription population as well as launch of newer brands such as Sprycel, Tasigna, Clolar and Arranon with no major patent expirations.
Cambridge MA) said the FDA will not allow the company to market its leukemia drug Clolar to previously untreated older adults unless it completes an additional clinical trial.
and ILEX Oncology, serving as CEO in both, where he led teams that were responsible for the clinical development of numerous important therapeutic products, four of which are currently used in the practice of medicine: Betaseron, Fludara, CAMPATH, and Clolar.
Genzyme, a maker of drugs for rare genetic disorders, agreed to buy New York-based Bioenvision to get exclusive rights to the leukemia drug clofarabine, sold as Clolar.
The committee will also review Ilex/Enzon's liposomal vincristine formulation Marqibo NDA (21-600) for relapsed aggressive non-Hodgkin's lymphoma and Ilex' Clolar (clofarabine) NDA (21-673) for pediatric patients (1-21 years) with refractory or relapsed acute leukemias on Dec 1.
The revenue of the leukemia treatment market has increased at a Compound Annual Growth Rate (CAGR) of 21% during the past eight years, due to the launch of new therapies including Sprycel (dasatinib), Tasigna (nilotinib), Clolar (cloferabine) and Arranon (nelarabine), which will continue to enjoy patent protection throughout the next six years covered by the report's forecast period.
Clofarabine, sold as Clolar, is used in children with acute lymphoblastic leukemia who have had relapses or failed other treatment.
This growth is attributed to the entry of premium priced products, and the market will be dominated by metabolic inhibitors such as midostaurin, from Novartis, an inhibitor of FLT-3 receptor tyrosine kinase, as well as Clolar (clofarabine), from Genzyme (Sanofi), an inhibitor of DNA polymerase.