Information Meeting on Polivy
Agenda
Moderator: Toshiya Sasai, Head of Corporate Communcations Dept.,
Chugai Pharmaceutical Co., Ltd.
1. Product Overview of Polivy
Dr. Takaki Koga, Polivy Lifecycle Leader, Chugai Pharmaceutical Co., Ltd.
- Treatment Options for Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Koji Izutsu, M.D., Ph.D., Department of Hematology, National Cancer Center Hospital
- Q&A Session
1
Product Overview
Polivy® Intravenous Infusion
30 mg/140 mg
June 3, 2021
Dr. Takaki Koga
Polivy Lifecycle Leader
Chugai Pharmaceutical Co., Ltd.
Product Outline
[Brand name]
Polivy® Intravenous Infusion 30 mg Polivy® Intravenous Infusion 140 mg
[Generic name] polatuzumab vedotin (genetical recombination)
[Indications]
Relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL)
3
Development History
Mar. 2011 Global phase I study started by Roche
Jul. 2014 Phase I study started in Japan
Oct. 2014 Global phase Ib/II study started in patients with R/R FL and DLBCL (GO29365)
Jun. 2017 PRIME designation (Europe)
Sep. 2017 Breakthrough Therapy designation (US)
Oct. 2018 Phase II study (P-DRIVE) started in patients with R/R DLBCL in Japan
Jun. 2019 Accelerated approval in the US
Nov. 2019 Orphan drug designation in Japan
Jan. 2020 Approved in Europe
Jun. 2020 Application for approval in Japan (R/R DLBCL)
Mar. 2021 Approved in Japan (33rd in the world)
FL: Follicular lymphoma
DLBCL: Diffuse large B-cell lymphoma
PRIME: Priority Medicines
Cited from the interview form of Polivy intravenous infusion 30 mg/140 mg [prepared in May 2021 (Ver.3)] | 4 |
Structure of Polivy (conceptual image)
Polivy is an antibody-drug conjugate (ADC) targeting CD79b1).
Binding site for CD79b2)
Fc domain (inactive)
Linkers cleavable by lysosomal protease3)
(Stable in circulating blood)
MMAE (monomethyl auristatin E):
Mitotic inhibitor that inhibits microtubule polymerization4)
1)Li D, et al. Br J Pharmacol. 2019; 176(19): 3805-3818. 2)Polson AG, et al. Expert Opin Investig Drugs. 2011; 20(1): 75-85.
3)Dornan D, et al. Blood. 2009; 114(13): 2721-2729. 4)Doronina SO, et al. Nat Biotechnol. 2003; 21(7): 778-784.
[COI: The literature 1, 2) includes the employees of Genentech. 5 The literature 3) includes the employees of Genentech and the authors funded by Genentech.]
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Chugai Pharmaceutical Co. Ltd. published this content on 03 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 June 2021 02:24:07 UTC.