Olaparib is under clinical development by AstraZeneca and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Olaparib’s likelihood of approval (LoA) and phase transition for Triple-Negative Breast Cancer (TNBC) took place on 12 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Olaparib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Olaparib overview

Olaparib (Lynparza) is an antineoplastic agent. It is formulated as hard gelatin capsules, coated tablets and film-coated tablets for oral route of administration. Lynparza is indicated for the treatment of the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and somatic) high grade serous epithelial ovarian, liposarcoma, bone arcoma, soft tissue sarcoma, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. Lynparza is indicated as monotherapy in patients with deleterious or suspected deleterious germline  BRCA  mutated advanced ovarian cancer who have been treated with three or more prior lines of  chemotherapy, and also indicated for the first line maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer, as a first line maintenance treatment for women with 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 1st-line platinum-based chemotherapy.Lynparza is also indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen, and also in combination with bevacizumab for first-line maintenance treatment of adult patients 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 positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Lynparza for 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 enzalutamide or abiraterone

It is under development for the treatment of metastatic pancreatic ductal adenocarcinoma, recurrent osteosarcoma, advanced pheochromocytoma and paraganglioma, metastatic colorectal cancer, castration sensitive recurrent non-metastatic prostate cancer, renal cell cancer second line therapy), triple negative breast cancer for adjuvant therapy, metastatic breast cancer (HER2+), gBRCAm HER negative breast cancer, ovarian cancer for first and second line therapy, intracranial glioma, neuroblastoma, recurrent endometrial cancer, relapsed glioblastoma, cholangiocarcinoma, non-small cell lung cancer, small-cell lung cancer, cervical cancer, malignant mesothelioma, soft tissue sarcoma, non-Hodgkin lymphoma, diffuse large B-cell lymphoma, Hodgkin lymphoma, gBRCA mutated metastatic pancreatic cancer, advanced squamous cell carcinoma of the head and neck (HNSCC), laryngeal carcinoma and oropharyngeal squamous cell carcinoma, metastatic urothelial carcinoma, Pancreatic Acinar Cell Carcinoma, gastric acncer, adenocarcinoma of gastroesophageal junction, metastatic uveal melanoma and advanced urothelial carcinoma.

It was also under development for colorectal cancer, HER2 negative metastatic breast cancer, gastric cancer including gastro-esophageal (GE) junction cancer and metastatic uterine leiomyosarcoma and first line unresectable stage IV bladder cancer, renal pelvic cancer, ureter cancer, urethral cancer and urothelial cancer and for second line therapy or greater BRCAm PSR ovarian cancer as maintenance monotherapy. It is under development for second and third line homologous-recombination deficient (HRD) metastatic colorectal cancer.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly-owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The COVID-19 Vaccine AstraZeneca has been approved for conditional marketing or emergency use. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

Quick View Olaparib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Olaparib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: AstraZeneca
  • Originator: KuDOS Pharmaceuticals
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.