Niraparib is under clinical development by GSK and currently in Phase II for Oral Cavity (Mouth) Cancer. According to GlobalData, Phase II drugs for Oral Cavity (Mouth) Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Niraparib LoA Report. Buy the report here.
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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.
Niraparib overview
Niraparib (MK-4827, Zejula) is an anti-neoplastic agent. It is formulated as hard gelatin capsules, tablets and film coated tablets for oral route of administration. Zejula is indicated for the treatment of adult patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy and also indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous-recombination deficient (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
It is under development for the treatment of advanced rectal cancer, recurrent glioblastoma, high-grade neuroendocrine carcinoma, advanced non-small cell lung cancer, recurrent and metastatic nasopharyngeal carcinoma, metastatic castration-sensitive prostate cancer (mCSPC), recurrent and metastatic head and neck squamous cell carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, recurrent glioblastoma, solid tumor, ovarian cancer, fallopian tube cancer, prostate cancer, pancreatic cancer, peritoneal cancer, metastatic urothelial cancer, gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, recurrent glioma, metastatic colorectal cancer, melanoma, advanced or metastatic solid tumors, metastatic invasive carcinoma of the cervix, esophageal cancer, gastroesophageal Junction and proximal gastric adenocarcinoma, uterine serous carcinoma, metastatic pancreatic cancer, recurrent epithelial ovarian, fallopian tube, metastatic pancreatic ductal adenocarcinoma, primary peritoneal cancer, solid tumors, small cell lung cancer, metastatic castration-resistant prostate cancer (CRPC), squamous non-small cell lung cancer, endometrial cancers, soft tissue sarcoma with at least one line of prior chemotherapy, mesothelioma, uveal melanoma, renal cell carcinoma and cholangiocarcinoma and pancreatic cancer. It is a new molecular entity (NME).
It was under development for the treatment of mantle cell lymphoma, breast cancer, astrocytoma, adenocarcinoma of the gastroesophageal junction, oligodendroglioma, recurrent glioblastoma, HR positive and HER2 negative recurrent gBRCA positive breast cancer, metastatic triple negative breast cancer, refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, Ewing's sarcoma rhabdomyosarcoma and metastatic biliary tract cancer.
GSK overview
GSK is a healthcare company that focuses on developing, manufacturing and commercializing general medicines, specialty medicines and vaccines. It offers drugs for the treatment of diseases such as HIV, respiratory, cancer, immuno-inflammation, anti-viral, central nervous system (CNS), metabolic, cardiovascular, and urogenital, anti-bacterial, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastrointestinal diseases. GSK’s vaccine portfolio covers various diseases including hepatitis, diphtheria, tetanus, whooping cough, rotavirus and HPV infections, measles and bacterial meningitis, among others. The company sells its products through wholesalers, pharmacies, hospitals, physicians and other groups worldwide. GSK is headquartered in Brentford, Middlesex, the UK.
For a complete picture of Niraparib’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.
