Capmatinib hydrochloride is under clinical development by Novartis and currently in the Phase I and Phase II 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 Capmatinib hydrochloride’s likelihood of approval (LoA) and phase transition for Glioblastoma Multiforme (GBM) took place on 13 Jan 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Capmatinib hydrochloride overview

Capmatinib hydrochloride (Tabrecta) is a potential antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Tabrecta is indicated as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Capmatinib (INC-280, INCB28060) is under development for the treatment of solid tumors including advanced hepatocellular carcinoma, gastric cancer, papillary renal cell carcinoma, metastatic triple negative breast cancer, non-small cell lung cancer, glioblastoma multiforme, and advanced or metastatic BRAF V600 melanoma. The drug candidate is administered orally. INC280 acts by targeting c-Met receptor tyrosine kinase (RTK). It was under development for head and neck cancer squamous cell carcinoma and recurrent glioblastoma multiforme.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View Capmatinib hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Capmatinib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Novartis
  • Originator: Incyte
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.