Opinion on Hematology in Europe

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Type Product title / description Pub Price
CommentWire
CommentWire

Pharmion: Vidaza takes first steps in Europe

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
16 Jan 2008
Expert View
Expert View

Biovest/Accentia's BiovaxID revives hope for therapeutic cancer vaccines

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
18 Jul 2008
CommentWire
CommentWire

Takeda/J&J: EU recommendation positions Velcade for first-line myeloma approval

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
28 Jul 2008
CommentWire
CommentWire

Janssen-Cilag: Velcade use extended in Europe

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
09 Sep 2008
CommentWire
CommentWire

Celgene: NICE negative recommendation to restrict Revlimid sales

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
30 Oct 2008
CommentWire
CommentWire

Genentech/Roche/Biogen Idec: Rituxan receives boost from leukemia data

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
09 Dec 2008
CommentWire
CommentWire

Cell Therapeutics: pixantrone to be submitted for FDA approval in NHL

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
27 Jan 2009
CommentWire
CommentWire

Cell Therapeutics: named EU patients to receive pixantrone for NHL

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
10 Feb 2009
CommentWire
CommentWire

Cell Therapeutics: pixantrone close to extending lymphoma treatment options

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
24 Jun 2009
Expert View
Expert View

ESMO 2009: denosumab as potential new treatment option for skeletal-related events in cancer

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
30 Sep 2009

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