Olaparib by AstraZeneca for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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. Lynparza is 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).
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 muscle-invasive bladder cancer (MIBC), 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 company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.
For a complete picture of Olaparib’s drug-specific PTSR and LoA scores, buy the report here.
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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
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