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News alerts, weekly reports and conference planners
Company:
Myriad GeneticsType:
FDA Approved
Related tests:
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Prostate Cancer-abiraterone/niraparib]
Source:
Title:
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer
Published date:
08/11/2023
Excerpt:
Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Prostate Cancer-abiraterone/niraparib]
Source:
Title:
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer
Published date:
08/11/2023
Excerpt:
Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Prostate Cancer-olaparib]
Source:
Published date:
05/31/2023
Excerpt:
...Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.
Secondary therapy:
abiraterone acetate + prednisone; abiraterone acetate + prednisolone
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Prostate Cancer-olaparib]
Source:
Published date:
05/31/2023
Excerpt:
...Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.
Secondary therapy:
abiraterone acetate + prednisolone; abiraterone acetate + prednisone
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-HER2 Negative Breast Cancer-olaparib]
Source:
Test:
BRACAnalysis CDx™
Published date:
03/11/2022
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2
(HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-HER2 Negative Breast Cancer-talazoparib]
Source:
Test:
BRACAnalysis CDx™
Published date:
10/16/2018
Excerpt:
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-HER2 Negative Breast Cancer-talazoparib]
Source:
Test:
BRACAnalysis CDx™
Published date:
10/16/2018
Excerpt:
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Ovarian Cancer-rucaparib]
Source:
Published date:
12/19/2016
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-) associated advanced ovarian cancer who have been treated with two or more chemotherapies.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Ovarian Cancer-rucaparib]
Source:
Published date:
12/19/2016
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-) associated advanced ovarian cancer who have been treated with two or more chemotherapies.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Peritoneal Cancer-bevacizumab + olaparib]
Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Peritoneal Cancer-bevacizumab + olaparib]
Source:
Excerpt:
"Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Ovarian Cancer-olaparib]
Source:
Test:
BRACAnalysis CDx™
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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza....for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA approved companion diagnostic for Lynparza.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Fallopian Tube Cancer-olaparib]
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: A1 - Approval
[BRCA1 mutation-Fallopian Tube Cancer-bevacizumab + olaparib]
Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Pancreatic Cancer-olaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma...
Secondary therapy:
Evidence Level:
Sensitive: A1 - Approval
[HRD-Fallopian Tube Cancer-bevacizumab + olaparib]
Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status...
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Pancreatic Cancer-olaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma...
Evidence Level:
Sensitive: A1 - Approval
[HRD-Peritoneal Cancer-bevacizumab + olaparib]
Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status...
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Fallopian Tube Cancer-olaparib]
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: A1 - Approval
[BRCA2 mutation-Fallopian Tube Cancer-rucaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation
(germline and/or somatic)-associated epithelial ovarian, fallopian tube, or
primary peritoneal cancer who have been treated with two or more
chemotherapies.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Peritoneal Cancer-rucaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Peritoneal Cancer-olaparib]
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: A1 - Approval
[BRCA1 mutation-Ovarian Cancer-olaparib]
Source:
Test:
BRACAnalysis CDx™
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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza....for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA approved companion diagnostic for Lynparza.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-HER2 Negative Breast Cancer-olaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Fallopian Tube Cancer-bevacizumab + olaparib]
Source:
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:...in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either....a deleterious or suspected deleterious BRCA mutation...
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Peritoneal Cancer-rucaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation
(germline and/or somatic)-associated epithelial ovarian, fallopian tube, or
primary peritoneal cancer who have been treated with two or more
chemotherapies.
Evidence Level:
Sensitive: A1 - Approval
[BRCA1 mutation-Fallopian Tube Cancer-rucaparib]
Source:
Test:
BRACAnalysis CDx™
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation
(germline and/or somatic)-associated epithelial ovarian, fallopian tube, or
primary peritoneal cancer who have been treated with two or more
chemotherapies.
Evidence Level:
Sensitive: A1 - Approval
[BRCA2 mutation-Peritoneal Cancer-olaparib]
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: C3 – Early Trials
[BRCA2 mutation-Ovarian Cancer-olaparib]
Source:
Title:
Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study.
Published date:
05/26/2022
Excerpt:
At DCO (June 25, 2021), median OS follow-up in censored pts was 42.6 mo in BRCAm and 39.3 mo in non-BRCA HRRm pts. OS and PFS2 are reported in the Table. PBC was received as a subsequent therapy by 33.1% BRCAm, 32.7% sBRCAm, 33.3% gBRCAm, and 45.5% non-BRCA HRRm pts...In final OS analyses, maintenance olaparib capsules showed consistent clinical activity in BRCAm and sBRCAm PSROC pts...
DOI:
10.1200/JCO.2022.40.16_suppl.5519
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
[BRCA1 mutation-Ovarian Cancer-olaparib]
Source:
Title:
Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study
Published date:
05/26/2022
Excerpt:
At DCO (June 25, 2021), median OS follow-up in censored pts was 42.6 mo in BRCAm and 39.3 mo in non-BRCA HRRm pts. OS and PFS2 are reported in the Table. PBC was received as a subsequent therapy by 33.1% BRCAm, 32.7% sBRCAm, 33.3% gBRCAm, and 45.5% non-BRCA HRRm pts...In final OS analyses, maintenance olaparib capsules showed consistent clinical activity in BRCAm and sBRCAm PSROC pts...
DOI:
10.1200/JCO.2022.40.16_suppl.5519
Trial ID:
