Lenvatinib mesylate by Eisai for Metastatic Biliary Tract Cancer: 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.

Lenvatinib mesylate overview

Lenvatinib mesylate (Lenvima / Kisplyx / Lenvixi) is a pyrrolopyrimidine derivative acts as anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Lenvima is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Lenvima is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentioated (papillary, follicular, Hurthel cell) thyroid carcinoma refractory to radioactive iodine and Kisplyx is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy and for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy and indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Lenvima is indicated for the treatment of unresectable thymic carcinoma and also indicated in combination with pembrolizumab for the first-line treatment of adult patients with advanced renal cell carcinoma.

It is also under development for the treatment of advanced adrenocortical cancer, malignant pleural mesothelioma, advanced/metastatic gastric cancer, metastatic esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma, melanoma, recurrent or metastatic head and neck squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, and/or larynx, locally advanced or metastatic gastrointestinal Stromal Tumor (GIST), pediatric diffuse intrinsic pontine glioma, recurrent or metastaticsalivary gland cancers, anaplastic thyroid cancer, merkel cell carcinoma, pancreatic ductal adenocarcinoma, relapsed and refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, medulloblastoma, ependymoma, high grade glioma, breast cancer, triple-negative breast cancer, endometrial cancer, renal cell carcinoma (second line), hepatocellular carcinoma, bladder cancer, locally advanced or metastatic non-squamous non-small cell lung cancer, endometrial cancer, urothelial cancer, biliary tract cancer, advanced gastric cancer, adenoid cystic carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer (RET translocations), thymic carcinoma, endometrial cancer, fallopian tube cancer, peritoneal cancer, recurrent head and neck cancer squamous cell carcinoma, colorectal cancer, cutaneous squamous cell carcinoma and epithelial ovarian cancer, ampullary carcinoma, gallbladder carcinoma, prostate cancer, HER2 negative breast cancer, human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP) and leptomeningeal metastases from any solid tumor and mixed carcinoma. It is also under development for solid tumors in combination with pembrolizumab and for advanced or metastatic non clear cell renal cell carcinoma who have not received any chemotherapy for advanced disease. 

It was also under development for the treatment of non-small cell lung cancer, lung adenocarcinoma, recurrent malignant glioma, liver fibrosis, endometrial cancer (monotherapy), melanoma and recurrent glioblastoma, metastatic melanoma, peripheral primitive neuroectodermal tumor (pPNET) and non-small cell lung cancer (third-line, monotherapy).

Eisai overview

Eisai is a pharmaceutical company that discovers, develops, manufactures and markets pharmaceuticals, including prescription medicines, OTC drugs and generics. The company’s franchise areas in research include neurology and oncology. Eisai’s major products include Pariet/AcipHex, a proton pump inhibitor; Aricept, an anti-Alzheimer agent; perampanel, Halaven, an anti-cancer agent; Fycompa tablets for the treatment of epilepsy and peripheral neuropathy. Eisai has production plants in Japan, the UK, China, and India and laboratories in Japan, the US and the UK; operations in the Americas, Asia and Latin America, EMEA and Oceania with overseas sales offices in the US, Germany, France, China and South Korea. Eisai is headquartered in Tokyo, Japan.

For a complete picture of Lenvatinib mesylate’s drug-specific PTSR and LoA scores, buy the report here.

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.