Lynparza (olaparib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	12
Lynparza 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.	15
Lynparza 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.	2
Lynparza 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.	2
Lynparza 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.	2
Lynparza 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.	4
Lynparza 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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
EMA (1)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
EMA (1)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
EMA (1)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
EMA (1)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
EMA (1)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
EMA (1)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
EMA (1)	HRD	Ovarian Epithelial Tumor	Bevacizumab, Olaparib
EMA (1)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
EMA (1)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
EMA (1)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
EMA (1)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
EMA (1)	HRD	High-Grade Serous Fallopian Tube Cancer	Bevacizumab, Olaparib
EMA (1)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
EMA (1)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
EMA (1)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
EMA (1)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
EMA (1)	HRD	Peritoneal Serous Carcinoma	Bevacizumab, Olaparib
EMA (2)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
EMA (2)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
EMA (1)	BRCA1 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
EMA (1)	BRCA2 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
EMA (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
EMA (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
EMA (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
EMA (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
EMA (1)	pMMR	Endometrial Carcinoma	Durvalumab, Olaparib