# GSK updates on Zejula prescribing information in US

- Link: https://www.directorstalkinterviews.com/gsk%c2%a0updates-on-zejula-prescribing-information-in-us/4121090031
- Published: 2022-11-11T07:22:56+00:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
LON/NYSE: GSK) has provided an update that at the request of the US Food and Drug
Administration (FDA) it will restrict the second-line maintenance indication for
_Zejula_ (niraparib) to only the patient population with deleterious or suspected
deleterious germline BRCA mutations (g_BRCA_mut). The US first-line indication of
_Zejula_ remains unchanged for the maintenance treatment of adult patients with 
advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have
a complete or partial response to platinum-based chemotherapy.

This decision follows an FDA review of the final overall survival (OS) analysis 
of the ENGOT-OV16/NOVA phase III trial, which served as the basis for the approval
of the second-line maintenance indication. In the final OS results from the NOVA
trial, the secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 (95%
CI: 0.81-1.37) in the non-g_BRCA_mut cohort.  

NOVA is a randomised, double-blind, placebo-controlled phase III trial of niraparib,
an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance
treatment of women with platinum-sensitive recurrent ovarian cancer. The primary
endpoint of the NOVA study was progression-free survival (PFS), evaluated as two
independently powered cohorts (g_BRCA_mut and non-g_BRCA_mut); results demonstrated
the clinically meaningful and statistically significant benefit of niraparib in 
both cohorts and across the HRD subgroups in the non-gBRCAmut cohort. Secondary 
endpoints were safety and long-term exploratory endpoints, including overall survival.
GSK is in ongoing discussions about these and other emerging OS data with health
authorities worldwide.

**About ovarian cancer** 

Ovarian cancer is the eighth most common cancer in women worldwide.^([i]) Despite
high response rates to platinum-based chemotherapy in the front-line setting, approximately
85% of patients will experience disease recurrence.^([ii]) Once the disease recurs,
it is rarely curable, with decreasing time intervals for each subsequent recurrence.

**About _Zejula _(niraparib)** 

_Zejula_ is an oral, once-daily PARP inhibitor currently being evaluated in multiple
pivotal trials. GSK is building a robust clinical development programme by assessing
activity across multiple tumour types and evaluating several potential combinations
of _Zejula_ with other therapeutics. The ongoing development programme includes 
several combination studies, including the FIRST phase III trial assessing niraparib
in combination with dostarlimab, a programmed death receptor-1 (PD-1)-blocking antibody,
as a potential treatment for first-line ovarian cancer maintenance and the phase
III ZEAL trial assessing niraparib in combination with standard of care for the 
maintenance treatment of first line advanced non-small cell lung cancer. GSK also
is evaluating niraparib in HER2-negative BRCA-mutated or triple-negative breast 
cancer. 

**Please see accompanying US prescribing information:**

[GSK-ZEJULA-CAPSULES-PI-PIL](https://www.directorstalkinterviews.com/wp-content/uploads/2022/11/GSK-ZEJULA-CAPSULES-PI-PIL.pdf)
[Download](https://www.directorstalkinterviews.com/wp-content/uploads/2022/11/GSK-ZEJULA-CAPSULES-PI-PIL.pdf)

_^([i]) Worldwide Cancer Data. World Cancer Research Fund. https://www.wcrf.org/
dietandcancer/cancer-trends/worldwide-cancer-data. Updated January 10, 2022. Accessed
July 2022._

_^([ii]) Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role
of secondary surgery in recurrent ovarian cancer [published online August 5, 2012].
Int J Surg Oncol. 2012. doi:10.1155/2012/613980. Accessed September 2022._

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