dm+d

35018611000001105

New Medicines

ZejulaAdvanced ovarian cancer - first-line maintenance therapy following first line platinum-based chemotherapy response

Information

Zejula
Licence extension / variation
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Launched
Launched
Launched
October 2020
Oct 20The EU has approved niraparib oral, once-daily PARP inhibitor, as first-line monotherapy maintenance treatment for patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response after platinum-based chemotherapy [9].
Sep 20Recommended for EU approval by CHMP - the additional indication is "as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy" [8].
Apr 20Approved by FDA. [6]
Feb 20Filed in EU as a maintenance first-line therapy in patients with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status [5].
Feb 20US FDA accepts sNDA for niraparib as first line maintenance treatment of ovarian cancer [4].

Category

PARP [poly (ADP-ribose) polymerase] inhibitor
The UK incidence of OC is 21 per 100,000 people. 75% have advanced disease and up to 80% respond to first-line platinum chemotherapy; of these 55-75% relapse within 2 years.
Advanced ovarian cancer - first-line maintenance therapy following first line platinum-based chemotherapy response
Oral

Further information

Yes
February 2021

Trial or other data

Oct 19GSK announced results from PRIMA (ENGOT-OV26/GOG-3012), the PIII randomised, double-blind, placebo-controlled study of niraparib as a maintenance therapy in women with 1st line ovarian cancer following a response to platinum-based chemotherapy. Niraparib treatment resulted in a 38% reduction in the risk of disease progression or death in the overall population (PFS, HR 0.62; 95% CI, 0.50–0.75; p<0.001) [3].
Jul 19GSK announce PIII PRIMA study met primary endpoint of a statistically significant improvement in PFS regardless of biomarker status [2].
Aug 18PIII PRIMA trial is active and no longer recruiting [1].
Apr 16PIII PRIMA trial to investigate whether the maintenance therapy of niraparib will extend the progression free survival in patients with first line ovarian cancer starts (PR30-5017C; NCT02655016). 620 patients will be recuirted in the US, Belgium, Czech Republic, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Norway, Poland, Russia, Spain, Switzerland, Ukraine and the UK. Primary outcome is progression free survival; collection of these data is due to complete Feb 20 [1].

Evidence based evaluations

Zejula Metastatic castration-resistant prostate cancer - first-line in combination with abiraterone and prednisone

Information

Zejula
Licence extension / variation
Janssen
Janssen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

PARP [poly (ADP-ribose) polymerase] inhibitor
Prostate cancer is the most common cancer in men and makes up 26% of all male cancer diagnoses in the UK. The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population [1].
Metastatic castration-resistant prostate cancer - first-line in combination with abiraterone and prednisone
Oral

Evidence based evaluations

Zejula Metastatic endometrial or ovarian carcinosarcoma - second-line in combination with dostarlimab

Information

Zejula
Licence extension / variation
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

An oral poly-(ADP-ribose) polymerase (PARP) inhibitor
Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS and uterine CS, have a 5-year overall survival <10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies), vast majority of patients relapse and receive diverse chemotherapy producing modest benefits, and nearly all patients will die [1].
Metastatic endometrial or ovarian carcinosarcoma - second-line in combination with dostarlimab
Oral