Risk Management & Treatment

PARP inhibitors 

PARP inhibitors are a type of targeted therapy that work by blocking a protein used to repair damaged DNA. They were initially developed to treat cancers in people with an inherited  BRCA1 or BRCA2 mutation. Since then, research and additional FDA approvals have expanded use of PARP inhibitors to more people and situations. There are four PARP inhibitors that have received FDA approval for treating different types of advanced cancers. 

Indications vary by:

  • type and stage of cancer: currently PARP inhibitors have been approved to treat breast, ovarian, pancreatic and prostate cancers. 
  • presence of a mutation or biomarker: PARP inhibitor have been approved in different settings for:  
    • people with certain inherited mutations.
    • people with certain acquired mutations.
    • people with certain tumor biomarkers.
    • women with certain types of ovarian cancer, regardless of inherited mutation or biomarker status.
  • number of and response to prior treatments: PARP inhibitor have been approved in different settings for:
    • platinum-sensitive or partially platinum sensitive ovarian cancer. 
    • metastatic, castration-resistant prostate cancer (mCRPC).
    • after chemotherapy. 
    • to treat progression or recurrence after a specific number of prior treatments. 

Clinical trials studying PARP inhibitors in new settings or combinations are enrolling patients. As research continues, these approvals may expand to include treatment for additional cancers, earlier stages of cancer, people with other inherited mutations, and based on different tumor biomarkers.

 

FDA- approved indications for PARP inhibitors

Cancer type       Indication  Biomarker or
inherited 
mutation
   
PARP inhibitor
Lynparza
olaparib
 Rubraca
rucaparib 
 Talzenna 
talazoparib 
 Zejula
niraparib 
Metastatic breast cancer For treatment of patients who have previously received chemotherapy, or hormone therapy for patients with hormone receptor (HR)-positive disease  Inherited BRCA1 or BRCA2 mutation and Her2-negative X      
Metastatic breast cancer For treatment of metastatic breast cancer Inherited BRCA1 or BRCA2 mutation and Her2-negative     X  
Stage 2-4 ovarian, fallopian tube or primary peritoneal  cancer First-line, maintenance therapy for women who had a complete or partial response to platinum chemotherapy Homologous Recombination Deficiency 
(HRD) testing
X
(combined with
Avastin)
     
Stage 2-4 ovarian, fallopian tube, or primary peritoneal  cancer First-line maintenance therapy for women who had a complete or partial response to platinum chemotherapy Inherited or acquired (tumor) mutation in BRCA1 or BRCA2 X      
Stage 2-4 ovarian, fallopian tube, or primary peritoneal  cancer First-line maintenance women who had a complete or partial response to platinum chemotherapy No inherited or acquired mutation or other tumor biomarker needed        X
Recurrent ovarian,  fallopian tube or primary peritoneal cancer Second-line (or later) maintenance therapy for platinum-sensitive or partially sensitive cancer  No inherited or acquired mutation or other tumor biomarker needed  X X   X
Recurrent ovarian, fallopian tube or primary peritoneal cancer Third-line (or later) treatment
for advanced ovarian cancer 
Inherited or acquired (tumor) mutation in BRCA1 or BRCA2   X    
Recurrent ovarian, fallopian tube or primary peritoneal cancer Fourth-line (or later) treatment for advanced ovarian cancer  Inherited mutation in BRCA1 or BRCA2 X      
Recurrent ovarian, fallopian tube or primary peritoneal cancer Fourth-line (or later) treatment for advanced ovarian cancer  BRCA mutation or
HRD-positive
      X
Metastatic pancreatic cancer  First-line maintenance therapy for patients whose disease has not progressed on at least 16 weeks of 
platinum-based chemotherapy
Inherited mutation in BRCA1 or BRCA2 X      
Metastatic castration-resistant prostate cancer (mCRPC) Men with mCRPC whose cancer has progressed following treatment with Xtandi (enzalutamide) or  Zytiga (abiraterone) Inherited mutation in BRCA1 or BRCA2 or
tumor mutation one of
the following genes: 
ATM, BRCA1, BRCA2, BARD1, BRIP1, CDK12, CHEK2, FANCL, PALB2, RAD51B, RAD51CRAD51D ,  RAD54
X      
Metastatic castration-resistant prostate cancer (mCRPC) Men with mCRPC who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy Inherited or acquired (tumor) mutation in BRCA1 or BRCA2   X    
Last updated August 06, 2020