Osimertinib mesylate is under clinical development by AstraZeneca and currently in Phase II for Non-Small Cell Lung Carcinoma. According to GlobalData, Phase II drugs for Non-Small Cell Lung Carcinoma have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Osimertinib mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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.
Osimertinib mesylate overview
Osimertinib mesylate (AZD-9291 / Tagrisso) acts as an antineoplastic agent. It is formulated as film coated tablets, coated tablets and tablets for oral route of administration. Tagrisso is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy and for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon-19 deletions or exon-21 L858R mutations). Tagrisso is indicated for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery.
Osimertinib mesylate is under development for the treatment of solid tumor including non-small cell lung cancer, squamous non-small cell lung cancer in combination with chemotherapy, non-small cell lung carcinoma, recurrent glioblastoma, lymphoma and refractory multiple myeloma. The drug candidate is a third-generation EGFR inhibitor. It is administered through oral route in the form of film-coated tablet.
The drug candidate was also under development for the treatment of leptomeningeal disease.
AstraZeneca overview
AstraZeneca is a biopharmaceutical company, that focuses on the discovery, production, and commercialization 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 Osimertinib mesylate’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.
