Olaparib

Chemical formula: C₂₄H₂₃FN₄O₃  Molecular mass: 434.463 g/mol 

Therapeutic indications

Olaparib is indicated for:

Monotherapy treatment of gBRCA1/2-mutated HER2-negative metastatic breast cancer

Population group: only adults (18 years old or older)

Olaparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

First-line maintenance treatment of MMR-Proficient advanced or recurrent endometrial cancer

Population group: only adults (18 years old or older)

Olaparib in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

First-line maintenance treatment of gBRCA-mutated metastatic adenocarcinoma of the pancreas

Population group: only adults (18 years old or older)

Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Monotherapy treatment of BRCA1/2-mutated metastatic castration-resistant prostate cancer

Population group: only adults (18 years old or older)

Olaparib is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Combination treatment of metastatic castration-resistant prostate cancer

Population group: only adults (18 years old or older)

Olaparib is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Adjuvant treatment of germline BRCA-mutated high risk early breast cancer

Population group: only adults (18 years old or older)

Olaparib is indicated as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

First-line maintenance treatment of HRD positive ovarian, fallopian tube, peritoneal cancer in combination with bevacizumab

Population group: only adults (18 years old or older)

Olaparib in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

First-line maintenance treatment of BRCA-mutated advanced ovarian cancer, fallopian tube or primary peritoneal cancer

Population group: only adults (18 years old or older)

Olaparib 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Maintenance treatment of platinum-sensitive relapsed ovarian cancer, fallopian tube, or primary peritoneal cancer

Population group: only adults (18 years old or older)

Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Olaparib is contraindicated in the following cases:

Pregnancy

Pregnancy

Lactation

Lactation

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