Dabrafenib mesylate is under clinical development by Novartis and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma). According to GlobalData, Phase II drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Dabrafenib mesylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Dabrafenib mesylate overview

Dabrafenib (Tafinlar) is a kinase inhibitor, acts as anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Tafinlar is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. In combination with Trametinib, it is indicted for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation as detected by an FDA-Approved test. Tafinlar in combination with trametinib, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSNLN) with a braf v600 mutation whose disease has progressed following systemic therapy. Tafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.

Dabrafenib is under development for the treatment of advanced refractory lymphoma, multiple myeloma, solid tumors such as non-small cell lung cancer, metastatic colorectal cancer, BRAF mutated thyroid carcinoma (papillary thyroid cancer, follicular thyroid cancer) and high grade glioma's including anaplastic astrocytoma, anaplastic pleomorphic xanthoastrocytoma , anaplastic gangliogliomas (aGG), glioblastoma, high-grade astrocytoma, biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL), non-seminomatous germ cell tumor/non-geminomatous germ cell tumor and paediatric low-grade glioma.

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, hematologic diseases, solid tumors, 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.

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

This content was updated on 2 September 2023

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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.