【drug-news】【资讯翻译】Kyprolis治疗多发性骨髓瘤的新药申请
发布于 2012-07-05 · 浏览 2186 · IP 北京北京
这个帖子发布于 12 年零 314 天前，其中的信息可能已发生改变或有所发展。
http://www.drugs.com/nda/kyprolis_120621.html
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South San Francisco, CA. — Jun. 20, 2012-Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis? (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.
“Today’s ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma,” said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. “Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review.”
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.
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请根据自己专业背景选择认领，如使用翻译软件翻译，被发现者扣分1-2分
请根据自己的专业背景选择相应的资讯认领，经常认领而不能及时提供优质稿件者将被列入黑名单，取消认领资格，请大家注意！
新近参与本次活动的会员请查看：【公告】动态版重启资讯翻译计划：我为人人，人人为我，共同提高
寻找最近的翻译贴请查看：http://search.dxy.cn/?words=%E8%B5%84%E8%AE%AF%E7%BF%BB%E8%AF%91&bid=116&t=1&c=1&age=7&bid=116&limit=30&o=1
翻译时请参照版规 【版务】科技动态版版规及加分细则（ 2014-02-21 更新）
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South San Francisco, CA. — Jun. 20, 2012-Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis? (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.
“Today’s ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma,” said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. “Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review.”
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.
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