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Olaparib

Generic Name
Olaparib
Brand Names
Lynparza
Drug Type
Small Molecule
Chemical Formula
C24H23FN4O3
CAS Number
763113-22-0
Unique Ingredient Identifier
WOH1JD9AR8

Overview

Olaparib is a selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP1 and PARP2. PARP inhibitors represent a novel class of anti-cancer therapy and they work by taking advantage of a defect in DNA repair in cancer cells with BRCA mutations and inducing cell death. Olaparib is used to treat a number of BRCA-associated tumours, including ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It was first approved by the FDA and EU in December 2014, and by Health Canada in April 2016.

Background

Olaparib is a selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP1 and PARP2. PARP inhibitors represent a novel class of anti-cancer therapy and they work by taking advantage of a defect in DNA repair in cancer cells with BRCA mutations and inducing cell death. Olaparib is used to treat a number of BRCA-associated tumours, including ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It was first approved by the FDA and EU in December 2014, and by Health Canada in April 2016.

Indication

Ovarian cancer Olaparib is indicated for the maintenance treatment of adults 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. Olaparib is indicated in combination with bevacizumab for the maintenance treatment of adults 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, and/or genomic instability. Olaparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Breast cancer Olaparib is 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. Olaparib is 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. Pancreatic cancer Olaparib is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Prostate cancer Olaparib is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a hormone agent, such as enzalutamide or abiraterone. It is also indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Associated Conditions

  • Advanced Epithelial Ovarian Cancer
  • Advanced Fallopian Tube Carcinoma
  • Advanced Primary Peritoneal Carcinoma
  • High risk, early breast cancer
  • Hormone Receptor Positive Breast Carcinoma
  • Locally Advanced Breast Cancer (LABC)
  • Metastatic Adenocarcinoma of the Pancreas
  • Metastatic Breast Cancer
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Pancreatic Adenocarcinoma Metastatic
  • Recurrent Epithelial Ovarian Cancer
  • Recurrent Fallopian Tube Cancer
  • Stage I Breast Cancer
  • Advanced high-grade epithelial ovarian cancer
  • Advanced, high-grade Primary Peritoneal Cancer
  • High-grade advanced Fallopian Tubes Cancer
  • Recurrent platinum sensitive primary peritoneal cancer
  • Relapsed Platinum-Sensitive Epithelial Ovarian Cancer
  • Relapsed platinum sensitive primary peritoneal cancer
  • Relapsed platinum-sensitive fallopian tube cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/17
Phase 2
Not yet recruiting
2025/05/13
Phase 3
Not yet recruiting
2025/04/07
Phase 3
Not yet recruiting
2025/04/04
Phase 2
Recruiting
2025/03/04
Phase 1
Not yet recruiting
2025/01/28
Phase 2
Recruiting
2025/01/20
N/A
Recruiting
Santa Chiara Hospital
2024/12/18
Phase 2
Recruiting
Tianjin Medical University Second Hospital
2024/12/02
Phase 3
Recruiting
2024/11/13
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AstraZeneca Pharmaceuticals LP
0310-0679
ORAL
150 mg in 1 1
11/6/2023
AstraZeneca Pharmaceuticals LP
0310-0668
ORAL
100 mg in 1 1
11/6/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
12/16/2014
Authorised
12/16/2014

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Olaparib Tablets
m/s natco pharma limited
国药准字HJ20250005
化学药品
片剂
1/8/2025
Olaparib Tablets
m/s natco pharma limited
国药准字HJ20250006
化学药品
片剂
1/8/2025
Olaparib Tablets
国药准字H20244040
化学药品
片剂
6/18/2024
Olaparib Tablets
国药准字H20233531
化学药品
片剂
5/12/2023
Olaparib Tablets
国药准字H20243888
化学药品
片剂
6/4/2024
Olaparib Tablets
国药准字H20243822
化学药品
片剂
5/28/2024
Olaparib Tablets
国药准字H20243063
化学药品
片剂
1/16/2024
Olaparib Tablets
国药准字H20243813
化学药品
片剂
5/28/2024
Olaparib Tablets
国药准字H20233532
化学药品
片剂
5/12/2023
Olaparib Tablets
国药准字HJ20180049
化学药品
片剂
3/20/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
LYNPARZA olaparib 150 mg film coated tablet blister pack
288614
Medicine
A
5/23/2018
LYNPARZA olaparib 100 mg film coated tablet blister pack
288613
Medicine
A
5/23/2018
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