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CommentWire
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Pharmion has submitted a Marketing Authorization Application with the EMEA for Vidaza in the treatment of patients with higher-risk myelodysplastic syndromes. If successful, it will become the first drug to be approved in the EU for MDS. However, Pharmion will need to establish a strong market position in the EU market in order to minimize the impact of future competition.
Published By Datamonitor
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16 Jan 2008 |
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Expert View
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Biovest, a subsidiary of Accentia, has announced positive data from a pivotal trial of BiovaxID in lymphoma, and the vaccine now stands a good chance of becoming the first therapeutic cancer vaccine to gain approval in the seven major markets. However, despite this breakthrough, a number of economical and logistical issues could prevent the vaccine from achieving significant market penetration.
Published By Datamonitor
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18 Jul 2008 |
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CommentWire
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Velcade is likely to receive EMEA approval following a positive opinion issued by the EU Committee for Medicinal Products for Human Use for use in previously untreated multiple myeloma patients. Velcade would see considerable uptake if the drug is approved in the first-line setting, due to its proven activity and favorable safety profile compared to current treatment regimens.
Published By Datamonitor
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28 Jul 2008 |
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CommentWire
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The EMEA has granted Velcade approval for use in the first-line treatment setting for multiple myeloma. With this line extension, Velcade will be available across all lines of multiple myeloma therapy, realizing its full commercial potential and offering a new treatment option to patients ineligible for bone marrow transplantation.
Published By Datamonitor
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09 Sep 2008 |
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CommentWire
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Revlimid has become the latest in a series of oncology drugs that have failed to satisfy NICE's cost-effectiveness criteria. As a result, Celgene's drug will not be available to multiple myeloma patients on the UK's National Health Service. The regulatory decision will restrict Revlimid's commercial potential with patients now likely to be switched to other treatments such as Thalomid and Velcade.
Published By Datamonitor
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30 Oct 2008 |
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CommentWire
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Rituxan is the most successful targeted therapy drug to date, having long been established as a standard in non-Hodgkin's lymphoma treatment. Regulatory approval in chronic lymphocytic leukemia will further drive the drug's sales potential. However, sales growth may be hindered in some markets due to Rituxan's existing off-label use.
Published By Datamonitor
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09 Dec 2008 |
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CommentWire
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Following discussions with the FDA, Cell Therapeutics will attempt to secure approval of pixantrone in relapsed aggressive non-Hodgkin's lymphoma before the end of 2009. Given the lack of a therapeutic standard within this indication, pixantrone's chances of approval are high.
Published By Datamonitor
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27 Jan 2009 |
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CommentWire
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US biopharmaceutical firm Cell Therapeutics has announced plans for a compassionate use program for pixantrone in patients with relapsed aggressive non-Hodgkin's lymphoma in Europe, expected to begin by the second quarter of 2009. While Cell Therapeutics has not announced detailed plans regarding pixantrone's EU development, the compassionate use program could ease EU market entry.
Published By Datamonitor
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10 Feb 2009 |
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CommentWire
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Having reported positive follow-up results for pixantrone from the pivotal Phase III EXTEND trial, Cell Therapeutics has now submitted a marketing application with the FDA for the drug in relapsed/refractory, aggressive non-Hodgkin's lymphoma. Pixantrone's chance of approval looks promising as it addresses an important unmet need for more effective third-line therapies in this population.
Published By Datamonitor
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24 Jun 2009 |
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Expert View
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Statistically significant positive results in two Phase III studies investigating denosumab in solid tumors and multiple myeloma have added to the ongoing excitement around Amgen's investigational product. These results, added to an impending decision from the FDA regarding approval, mean that a new treatment option for bone metastases in cancer patients could be on the market within months.
Published By Datamonitor
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30 Sep 2009 |
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