^
Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Title:

Lynparza approved in China as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer

Published date:
12/05/2019
Excerpt:
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the companies have received marketing authorisation from China’s National Medical Products Administration (NMPA) for Lynparza (olaparib) as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Published date:
12/05/2018
Excerpt:
AusPAR...Olaparib is indicated as monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Title:

Health Canada approves LYNPARZA for the Treatment of Ovarian Cancer with BRCA-Mutations

Published date:
05/03/2016
Excerpt:
AstraZeneca Canada announced today that Health Canada has approved LYNPARZA (olaparib) capsules as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
Evidence Level:
Sensitive: A1 - Approval
Excerpt:
Lynparza is indicated as monotherapy for the:...maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
Ovarian cancer/Fallopian Tube cancer/Primary Peritoneal cancer: NCCN Recommended Options for Maintenance After First-Line Chemotherapy:...BRCA1/2 mutated...Recommended Options...olaparib.
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm): Phase III SOLO1 trial

Published date:
11/01/2018
Excerpt:
SOLO1 is a randomized, controlled, double-blind trial. Eligible pts had newly diagnosed, FIGO stage III–IV, high-grade serous or endometrioid ovarian, primary peritoneal and/or fallopian tube cancer with a BRCAm….Maintenance olaparib led to a substantial, unprecedented improvement in PFS, with an estimated difference in median PFS for olaparib versus placebo of approximately 3 years.
DOI:
10.1093/annonc/mdy483.002
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Excerpt:
The use of maintenance therapy with olaparib provided a substantial benefit with regard to progression-free survival among women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation, with a 70% lower risk of disease progression or death with olaparib than with placebo.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Excerpt:
...Difference in levels of PAR or PARP-1 before and after study treatment`Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A study, performed in several centers, to examine the treatment of Olaparib at the time of disease progression in ovarian, peritoneal or fallopian tube cancer before an operation.

Excerpt:
...• Biological effects in the primary tumour following a short pre-operative course of treatment with Olaparib in patients with platinum sensitive relapsed ovarian cancer; the biological effects are assess in terms of the degree of PAR or PARP-1 inhibition (in tissue and ctDNA) • Germline HRD mutations and tissue mutation with respect to BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 (in tissue and ctDNA)• Generate initial clinical efficacy data for future studies (RECIST 1.1)...
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers

Excerpt:
...Men with BRCA1/2 mutation and metastatic breast cancer will be eligible for study....
Trial ID: