Drug products: Lynparza, Olaparib
ATC code: L01XK01
At present studies concerning differences between men and women are limited as the approved indication only includes women.
Olaparib is an oral poly ADP ribose polymerase (PARP) inhibitor. Indications are previously treated BRCA-positive or suspected BRCA-positive germline BRCA-mutated (gBRCAm) advanced ovarian cancer, maintenance treatment of recurrent epithelial ovarian, fallopian tube, or peritoneal cancer after response to platinum-based chemotherapy, previously treated HER2-negative and gBRCAm metastatic breast cancer . There are studies indicating a positive effect also in men with certain types of prostate cancer [3-5]. Also, in pancreatic cancer the drug may be effective and has received orphan drug destination for this indication both by EMA and FDA .
Pharmacokinetics and dosing
No studies with a clinically relevant sex analysis regarding pharmacokinetics of olaparib have been found
No studies with a clinically relevant sex analysis regarding effect of olaparib have been found
No studies with a clinically relevant sex analysis regarding adverse effects of olaparib have been found
Reproductive health issues
Olaparib should be avoided during pregnancy as data is lacking but animal studies indicate an increased risk of teratogenic effects and risk of still birth. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2018-12-06
- Physicians' Desk Reference. http://www.pdr.net. [cited 2018-12-06]. länk
- Fass.se [cited 2018-12-06]. länk
- Karzai F, VanderWeele D, Madan RA, Owens H, Cordes LM, Hankin A et al. Activity of durvalumab plus olaparib in metastatic castration-resistant prostate cancer in men with and without DNA damage repair mutations. J Immunother Cancer. 2018;6(1):141. PubMed
- Clarke N, Wiechno P, Alekseev B, Sala N, Jones R, Kocak I et al. Olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2018;19(7):975-986. PubMed
- Martin GA, Chen AH, Parikh K. A Novel Use of Olaparib for the Treatment of Metastatic Castration-Recurrent Prostate Cancer. Pharmacotherapy. 2017;37(11):1406-1414. PubMed
- Gina Columbus. FDA Grants Olaparib Orphan Drug Designation for Pancreatic Cancer. OncLive [www]. [cited 2018-12-06]. länk
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-12-06.] länk
Reviewed by: Karin Schenck-Gustafsson
Approved by: Karin Schenck-Gustafsson