PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of pembrolizumab for locally advanced uterine cervical cancer, and durvalumab and olaparib for advanced or recurrent endometrial cancer in Japan

被引：1

作者：

Matsumura, Noriomi ^{[1
,2
]}

Mandai, Masaki ^{[2
,3
]}

机构：

[1] Kindai Univ, Fac Med, Osaka, Japan

[2] Japan Soc Clin Oncol, Editorial Comm, Tokyo, Japan

[3] Kyoto Univ, Grad Sch Med, Kyoto, Japan

来源：

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY | 2025年 / 30卷 / 02期

关键词：

D O I：

10.1007/s10147-024-02679-w

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

引用

页码：170 / 171

页数：2

共 4 条

[1] Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed high-risk, locally advanced cervical cancer (ENGOT-cx11/ GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial [J].

Lorusso, Domenica ;

Xiang, Yang ;

Hasegawa, Kosei ;

Scambia, Giovanni ;

Leiva, Manuel ;

Ramos-Elias, Pier ;

Acevedo, Alejandro ;

Cvek, Jakub ;

Randall, Leslie ;

Gomes, Andrea Juliana Pereira de Santana ;

Mejia, Fernando Contreras ;

Helpman, Limor ;

Akilli, Huseyin ;

Lee, Jung-Yun ;

Saevets, Valeriya ;

Zagouri, Flora ;

Gilbert, Lucy ;

Sehouli, Jalid ;

Tharavichitkul, Ekkasit ;

Lindemann, Kristina ;

Colombo, Nicoletta ;

Chang, Chih-Long ;

Bednarikova, Marketa ;

Zhu, Hong ;

Oaknin, Ana ;

Christiaens, Melissa ;

Petru, Edgar ;

Usami, Tomoka ;

Liu, Peng ;

Yamada, Karin ;

Toker, Sarper ;

Keefe, Stephen M. ;

Pignata, Sandro ;

Duska, Linda R. .

LANCET, 2024, 404 (10460) :1321-1332

[2] Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/ GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial [J].

Lorusso, Domenica ;

Xiang, Yang ;

Hasegawa, Kosei ;

Scambia, Giovanni ;

Leiva, Manuel ;

Ramos-Elias, Pier ;

Acevedo, Alejandro ;

Sukhin, Vladyslav ;

Cloven, Noelle ;

Gomes, Andrea J. Pereira de Santana ;

Mejia, Fernando Contreras ;

Reiss, Ari ;

Ayhan, Ali ;

Lee, Jung-Yun ;

Saevets, Valeriya ;

Zagouri, Flora ;

Gilbert, Lucy ;

Sehouli, Jalid ;

Tharavichitkul, Ekkasit ;

Lindemann, Kristina ;

Lazzari, Roberta ;

Chang, Chih-Long ;

Lampe, Rudolf ;

Zhu, Hong ;

Oaknin, Ana ;

Christiaens, Melissa ;

Polterauer, Stephan ;

Usami, Tomoka ;

Li, Kan ;

Yamada, Karin ;

Toker, Sarper ;

Keefe, Stephen M. ;

Pignata, Sandro ;

Duska, Linda R. .

LANCET, 2024, 403 (10434) :1341-1350

[3]

Pharmaceuticals and Medical Devices Agency, 2024, LIST APPROVED DRUGS

[4] Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial [J].

Westin, Shannon N. ;

Moore, Kathleen ;

Chon, Hye Sook ;

Lee, Jung-Yun ;

Pepin, Jessica Thomes ;

Sundborg, Michael ;

Shai, Ayelet ;

de la Garza, Joseph ;

Nishio, Shin ;

Gold, Michael A. ;

Wang, Ke ;

Mcintyre, Kristi ;

Tillmanns, Todd D. ;

Blank, Stephanie V. ;

Liu, Ji-Hong ;

Mccollum, Michael ;

Mejia, Fernando Contreras ;

Nishikawa, Tadaaki ;

Pennington, Kathryn ;

Novak, Zoltan ;

De Melo, Andreia Cristina ;

Sehouli, Jalid ;

Klasa-Mazurkiewicz, Dagmara ;

Papadimitriou, Christos ;

Gil-Martin, Marta ;

Brasiuniene, Birute ;

Donnelly, Conor ;

del Rosario, Paula Michelle ;

Liu, Xiaochun ;

Van Nieuwenhuysen, Els .

JOURNAL OF CLINICAL ONCOLOGY, 2024, 42 (03) :283-299

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