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PARP inhibitors as maintenance therapy:

Where do we stand in sensitive relapsed ovarian cancer by Regulatory Agencies ?

ZEJULA™ [package insert]. Waltham, MA: TESARO, Inc.; 2017; ZEJULA™ [product information] London, UK: TESARO, UK Ltd.; 2017 LynparzaTM [package insert].

Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017; LynparzaTM [product information]. Cheshire, UK: AstraZeneca UK Limited; 2017; Rubraca

®

(rucaparib) [package

insert]. Boulder, CO: Clovis Oncology, Inc: 2017; “Clovis Oncology’s rucaparib significantly improved progression-free survival in all ovarian cancer patient Populations

Studied in Phase 3 ARIEL3 maintenance treatment trial”; news release, 2017.

Available at:

http://phx.corporate-ir.net/phoenix.zhtml?c=247187&p=irol-newsArticle&ID=2281511.

Accessed 7 August 2017

1. Mirza MR, et al.

N Engl J Med

2016;375:2154–64; 2. Ledermann J, et al.

Lancet Oncol

2014;15:852–61

3. Pujade-Lauraine E, et al.

Lancet Oncol

2017;18:1274–84; 4. Coleman RL, et al.

Lancet

2017;390:1949‒61

United

States

Europe

Maintenance treatment

of adult

patients with recurrent epithelial

ovarian, fallopian tube or primary

peritoneal cancer

regardless of

BRCA

status

Maintenance treatment

of adult

patients with recurrent epithelial

ovarian, fallopian tube or primary

peritoneal cancer

regardless of

BRCA

status

Maintenance treatment

of adult

patients with recurrent epithelial

ovarian, fallopian tube or primary

peritoneal cancer

regardless of

BRCA

status

Maintenance treatment

of adult

patients with

high-grade serous

epithelial ovarian, fallopian tube or

primary peritoneal cancer

regardless of

BRCA

status

Maintenance treatment

of adult

patients with recurrent epithelial

ovarian, fallopian tube or primary

peritoneal cancer

regardless of

BRCA

status

Maintenance treatment

of adult

patients with recurrent epithelial

ovarian, fallopian tube or primary

peritoneal cancer

regardless of

BRCA

status

ENGOT-OV16 / NOVA

1

Study 19

2

SOLO-2

3

ARIEL3

4

Key

trials

Niraparib

Olaparib

Rucaparib