Published: 2012-7-24 Source: Love only medical research and development for new anti-cancer drugs, the July 20, 2012 was a good day, the European Medicines Agency (EMA) today approved the three kinds of anti-cancer drugs, only dismissed one kind. Pfizer's Xalkori (crizotinib), Takeda Pharmaceuticals ricina Adcetris (brentuximab vedotin) and Janssen's Dake (decitabine) were successfully approved, and Celgene's Istodax (romidepsin) is not nominated. In very few cases of lung cancer drugs, EMA decided to defer believe the role of Xalkori. Authorities under the Commission has recommended medicines for human use granted conditional marketing authorization for its indication for individual non-small cell lung cancer (NSCLC) therapy - all of authorization must seek permission of the European Commission, the drug and the adaptation permit has been approved by the FDA last August ("Pfizer's Xalkori Joins The Six-Figure Oncology Drug Club" - "The Pink Sheet," Sep. 5, 2011). Conditional authorization reflects the nature CHMP position that Xalkori apparently fill the gaps in this field of medicine, and has a good benefit / risk spectrum, however, CHMP still require Pfizer to provide additional data on the drug. According to the American experience in the application crizotinib, an estimated treatment costs between $ 52,800 ~ 76,800 / year. But for patients who survived more than a year, the cost of treatment of the drug may rise to more than $ 115,000. Taking into account the European health care budget constraints, such a high figure could unacceptable. Another drug CHMP meeting this week to win for Dake, the drug is proposed to grant marketing authorization for the treatment of patients 65 years and older with acute myeloid ricina leukemia. For Dake improve overall survival ability, ricina determination CHMP results in stark contrast with the FDA pivotal study based on refusal to approve the indication, the study failed to show an initial analysis of the drug has a preset statistically significant The survival benefit ("Dacogen Leukemia ricina Indication Would Require New Clinical Trial, FDA Tells Eisai" - "The Pink Sheet" DAILY, Mar. 7, 2012). Finally, to get a drug approved by the EMA Adcetris. CHMP is only recommended to grant this antibody - drug binding material conditional marketing authorization for indications related ricina to the specific indications for adult patients with relapsed or refractory systemic anaplastic large cell lymphoma and relapsed or refractory CD30 + Hodgkin's lymphoma. For Hodgkin's lymphoma is concerned, this authorization has been limited to the treatment of autologous stem cell transplantation (ASCT) after ASCT or when not to take drugs or chemotherapy treatment, the use of at least two kinds of treatment programs after application. U.S. FDA for the drug patent holder - Seattle Genetics Corporation (Seattle Genetics) accelerated approval of the drug ("Seattle Genetics Commits To Simultaneous Confirmatory Trials For Adcetris" - "The Pink Sheet" DAILY, Aug. 19, 2011 ). The only shortcoming is that day EMA refused to recommend Celgene's ricina Istodax for the treatment of peripheral T-cell lymphoma. Celgene submitted relevant evidence obtained by the individual clinical trials, the trial involved ricina 131 cases of patients, but it is not one of the drug with any other treatment were compared, which is its fatal flaw, CHMP said that the study design so that the test can not draw any conclusions about the drug's clinical benefit. It also added that the test can not evaluate the drug compared with other current treatment effect on overall survival or progression-free survival. Obviously, this is a blow for T-cell lymphoma patients, currently in the EU in fewer medicines to treat the disease, the drug has therefore in October 2005 was awarded orphan drug qualified. Celgene can submit the application for review within 15 days of receipt of the notification. In the United States, Istodax on November 5, 2009 through the approval ("Gloucester's Istodax Gains FDA Approval Ahead Of New Regulatory Requirements" - "The Pink Sheet" DAILY, Nov. 6, 2009).
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