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[求助]
求助来那替尼上市信息？ 已有1人参与
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| 在网上看到有公司挂来那替尼项目合作信息，在CDE上有来那替尼片的进口申请，但是我却查不到该药的具体上市信息，特此求助，望大侠相帮，谢谢！ |
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Puma Biotechnology, under license from Pfizer (previously Wyeth), is developing neratinib (PB-272; HKI-272), an irreversible pan-HER (Erbb1, ErbB2 and ErbB4) tyrosine kinase inhibitor, for the potential oral treatment of HER2-positive cancers, primarily breast cancer In July 2009, worldwide phase III breast cancer trials were initiated by Wyeth in patients who had received prior trastuzumab-based therapy ; in October 2011, following its acquisition of rights, Puma intended to terminate the ongoing Pfizer-sponsored trials , and the company began its own phase III trial in third-line metastatic breast cancer in June 2013 . In July 2014, Puma planned to file the drug for approval in the extended adjuvant setting for breast cancer in 1H15 . Development in other HER2-positive cancer settings is ongoing. In April 2013, a phase II trial in patients with NSCLC was ongoing . In October 2013, a phase II study in patients with other solid tumors with a HER2 mutation was initiated ; in March 2014, initial data from the trial were expected in 2014 |
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4楼2014-08-28 08:46:35
7楼2014-08-28 11:20:00
8楼2014-08-28 11:22:08
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Puma Biotechnology, under license from Pfizer (previously Wyeth), is developing neratinib (PB-272; HKI-272), an irreversible pan-HER (Erbb1, ErbB2 and ErbB4) tyrosine kinase inhibitor, for the potential oral treatment of HER2-positive cancers, primarily breast cancer In July 2009, worldwide phase III breast cancer trials were initiated by Wyeth in patients who had received prior trastuzumab-based therapy ; in October 2011, following its acquisition of rights, Puma intended to terminate the ongoing Pfizer-sponsored trials , and the company began its own phase III trial in third-line metastatic breast cancer in June 2013 . In July 2014, Puma planned to file the drug for approval in the extended adjuvant setting for breast cancer in 1H15 . Development in other HER2-positive cancer settings is ongoing. In April 2013, a phase II trial in patients with NSCLC was ongoing . In October 2013, a phase II study in patients with other solid tumors with a HER2 mutation was initiated ; in March 2014, initial data from the trial were expected in 2014 |
10楼2014-08-28 18:00:06
