Binimetinib is under clinical development by Pfizer and currently in the 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 Binimetinib’s likelihood of approval (LoA) and phase transition for Metastatic Brain Tumor took place on 13 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Binimetinib overview

Binimetinib (Mektovi) is a halobenzoic acid derivative, acts as anticancer agent. It is formulated as film coated tablets and coated tablets for oral route of administration. Mektovi is indicated for the treatment of  patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation and BRAF mutant colorectal cancer.

Binimetinib (MEK-162, ARRY-162) is under development for the treatment of solid tumors including advanced, unresectable or metastatic cutaneous melanoma, metastatic thyroid cancer, triple-negative breast cancer, metastatic colorectal cancer, metastatic uveal melanoma, relapsed or refractory acute myeloid leukemia and acute lymphocytic leukemia, metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma, chronic myelocytic leukemia, philadelphia positive acute leukemia, gastrointestinal stromal tumor, hepatocellular carcinoma, advanced non-small cell lung cancer, esophageal cancer and neurofibromatoses type I associated with plexiform neurofibroma. The drug candidate was also under development for the treatment of pancreatic ductal adenocarcinoma, rheumatoid arthritis (RA), metastatic pancreatic adenocarcinoma, small-cell lung cancer, hypertropic cardiomyopathy, ovarian cancer, fallopian tube cancer, peritoneal cancer, melanoma, esophageal cancer, brain metastases and metastatic uveal melanoma.

Pfizer overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

Quick View Binimetinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Binimetinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Genetic Disorders
  • Immunology
  • Non Malignant Disorders
  • Oncology
Key Developers
  • Sponsor Company: Pfizer
  • Originator: Array BioPharma
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.