[{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis data at ASCO and EHA showcase bold approaches to reimagine cancer and blood disorders through multiple therapeutic platforms","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"The University of Texas MD Anderson Cancer Center","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Targeted Therapy Combination Effective for Patients with Advanced Cholangiocarcinoma and Braf Mutations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small 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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Tafinlar + Mekinist Receives FDA Approval for First Tumor-Agnostic Indication for BRAF V600E Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Spirita Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Spirita Oncology, LLC Initiates a Phase 1 Clinical Trial of the Anti-Cancer Agent E6201 in Combination with Dabrafenib in Patients with Central Nervous System Metastases from BRAF V600 Mutated Metastatic Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular 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Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Reports Late-Breaking Data from Phase III COMBI-i Trial of Spartalizumab (PDR001) with Tafinlar\u00ae and Mekinist\u00ae in Advanced Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Announces Long-Term, Relapse-Free Survival Benefit for High-Risk, Stage III Melanoma Patients Treated with Tafinlar\u00ae + Mekinist\u00ae Following Surgery","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Dabrafenib
Tafinlar is a combination of dabrafenib mesylate and trametinib that targets two different kinases in the RAS/RAF/MEK/ERK pathway. This combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines.
JSI-1187 is a selective and orally administered small molecule inhibitor of ERK1 and ERK2. In preclinical studies, JSI-1187 demonstrated high potency against a variety of tumors with MAPK pathway mutations.
E6201 is an ATP-competitive MEK1 inhibitor that has demonstrated preclinical activity in BRAF V600-mutant melanoma cell lines. E6201 has shown excellent brain distribution characteristics and minimal CNS efflux by transporters at the BBB.
FDA approval was based on clinical efficacy and safety demonstrated in three clinical trials. In Phase II ROAR basket study and NCI-MATCH Subprotocol H study, Tafinlar (dabrafenib mesylate) + Mekinist resulted in overall response rates of up to 80% in patients with BRAF V600E.
Treatment with targeted therapies Tafinlar (dabrafenib)+ Mekinist resulted in 47% ORR versus chemotherapy and reduced risk of progression or death by 69%, showing significant efficacy improvement in patients with BRAF V600 LGG requiring first systemic treatment.
In a paper published by Science Advances, Creighton scientists and students involved in the research found that dabrafenib can be repurposed to prevent cisplatin- and noise-induced hearing loss in mice.
Tafinlar (dabrafenib) and Mekinist (trametinib) are approved in combination to treat people with a type of skin cancer called melanoma, non-small cell lung cancer and anaplastic thyroid cancer.
PDR001 (spartalizumab) is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor. Its development program continues, and investigating the immunotherapy across a range of tumor types.
In a Phase II trial a combination targeted therapy achieved a 51% overall response rate in patients with cholangiocarcinoma and BRAF V600E mutations. This is the first prospective study for this group of patients.
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