Delving into the Latest Updates on Dabrafenib Mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN)

+ [18]

Target

BRAF x CRAF

Mechanism

BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [8]

Active Indication

BRAF mutation positive hairy cell leukemiaBRAF mutation Solid TumorsHigh grade glioma+ [37]

Inactive Indication

AmeloblastomaBRAF V600K Mutation-Positive Solid TumorsBRAF-mutation brain cancer+ [7]

Originator Organization

GSK Plc

Active Organization

Novartis Pharmaceuticals Corp.Novartis Korea Ltd.Novartis Pharma AG

+ [6]

Inactive Organization

JS InnoPharm (Shanghai) Co., Ltd.

GlaxoSmithKline (China) Investment Co., Ltd.GlaxoSmithKline Biologicals SA

+ [1]

Drug Highest PhaseApproved

First Approval Date

US (29 May 2013),

BRAF V600E Mutation-Positive Melanoma

RegulationFast Track (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Orphan Drug (KR), Priority Review (AU), Breakthrough Therapy (US), Orphan Drug (US)

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Structure

Molecular FormulaC24H24F3N5O5S3

InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N

CAS Registry1195768-06-9

Pediatric gliomas harboring BRAF-alterations, commonly BRAFV600 mutation or KIAA1549-BRAF fusion, are currently treated with either chemotherapy or mitogen activated protein kinase (MAPK) inhibitors, such as, dabrafenib and/or trametinib. Unfortunately, some BRAF-altered gliomas can progress or have rebound growth after discontinuation of therapy. Data from BRAFV600E-mutant melanoma has shown potential synergy between MAPK inhibition and anti-programmed cell death 1 (anti-PD1) checkpoint blockade. Anti-PD1 therapy, such as, nivolumab can block the PD1 receptor on T cells, a marker of T cell exhaustion, allowing a continued or more robust anti-tumor immune response. Here, we combine MAPK inhibition with anti-PD1 therapy in recurrent, refractory low grade BRAF-altered glioma and newly diagnosed or recurrent BRAF-altered or NF-altered high grade glioma.

Start Date01 Dec 2024

Sponsor / Collaborator

Ann & Robert H. Lurie Children's Hospital of Chicago

ChiCTR2400091473 / SuspendedNot ApplicableIIT

Redifferentiation of radiodine-refractory metastatic papillary thyroid carcinoma with BRAFV600E mutation by dabrafenib in combination with trametinib

Start Date01 Nov 2024

Sponsor / Collaborator-

NCT06563999 / RecruitingPhase 2IIT

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

Start Date01 Nov 2024

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Dabrafenib Mesylate

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100 Translational Medicine associated with Dabrafenib Mesylate

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100 Patents (Medical) associated with Dabrafenib Mesylate

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1,721

Literatures (Medical) associated with Dabrafenib Mesylate

01 Apr 2025·DEN open

Dynamic endoscopic progression of gastrointestinal tract involvement in Langerhans cell histiocytosis: A pediatric case report

Article

Author: Li, Zhongyue ; Liu, Bo ; Zhang, Huihua ; Pan, Jianwei

Abstract:

Gastrointestinal tract involvement in Langerhans cell histiocytosis (LCH) is extremely rare, with limited documentation of endoscopic manifestations. We report a 19‐month‐old girl who presented with repeated diarrhea and bloody stools, accompanied by recurrent pulmonary infections, anemia, hypoproteinemia, thrombocytopenia, coagulopathy, and hepatosplenomegaly with lymphadenopathy. Initial treatment with antibacterial agents, mesalazine, thalidomide, and prednisone led to temporary improvement; however, the symptoms repeatedly relapsed. She underwent three digestive endoscopies, but until the third endoscopy, a definitive diagnosis of Langerhans cell histiocytosis was established through biopsy. While upper gastrointestinal tract findings were not significant, notable changes were observed in the colorectal region. A colonoscopy revealed progression from erythema to diffuse hyperemia and edema, with erythema, erosion, and superficial ulcers extending into the distal ileal mucosa. Genetic analysis identified a BRAF‐V600E mutation. Following treatment with chemotherapy (vincristine and prednisone) and the BRAF inhibitor dabrafenib, the patient demonstrated significant clinical improvement within days. At the 1‐year follow‐up, the patient had normal bowel movements and a weight gain of 2.5 kg. Early gastrointestinal endoscopy with multiple biopsies in suspected children can facilitate early detection. Dabrafenib is a viable treatment option for Langerhans cell histiocytosis.

01 Jan 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

A comprehensive review of targeting RAF kinase in cancer

Review

Author: Hossain, Md Arafat ; Hossain, Md. Arafat

RAF kinases, particularly the BRAF isoform, play a crucial role in the MAPK/ERK signaling pathway, regulating key cellular processes such as proliferation, differentiation, and survival. Dysregulation of this pathway often caused by mutations in the BRAF gene or alterations in upstream regulators like Ras and receptor tyrosine kinases contributes significantly to cancer development. Mutations, such as BRAF-V600E, are present in a variety of malignancies, with the highest prevalence in melanoma. Targeted therapies against RAF kinases have achieved substantial success, especially in BRAF-V600E-mutant melanomas, where inhibitors like vemurafenib and dabrafenib have demonstrated remarkable efficacy, leading to improved patient outcomes. These inhibitors have also shown clinical benefits in cancers such as thyroid and colorectal carcinoma, although to a lesser extent. Despite these successes, therapeutic resistance remains a major hurdle. Resistance mechanisms, including RAF dimerization, feedback reactivation of the MAPK pathway, and paradoxical activation of ERK signaling, often lead to diminished efficacy over time, resulting in disease progression or even secondary malignancies. In response, current research is focusing on novel therapeutic strategies, including combination therapies that target multiple components of the pathway simultaneously, such as MEK inhibitors used in tandem with RAF inhibitors. Additionally, next-generation RAF inhibitors are being developed to address resistance and enhance therapeutic specificity. This review discusses the clinical advancements in RAF-targeted therapies, with a focus on ongoing efforts to overcome therapeutic resistance and enhance outcomes for cancer patients. It also underscores the persistent challenges in effectively targeting RAF kinase in oncology.

01 Jan 2025·LUNG CANCER

Real-world efficacy of the dabrafenib-trametinib (D-T) combination in BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC): Results from the IFCT-2004 BLaDE cohort

Article

Author: Tomasini, Pascale ; Pichon, Eric ; Morin, Franck ; Domblides, Charlotte ; Debieuvre, Didier ; Geier, Margaux ; Bayle-Bleuez, Sophie ; Larivé, Sébastien ; Couraud, Sébastien ; Fabre, Elizabeth ; Lerolle, Ulrike ; Swalduz, Aurélie ; Beau-Faller, Michèle ; Planchard, David ; Daniel, Catherine ; Wislez, Marie ; Missy, Pascale ; Cortot, Alexis ; Mazieres, Julien ; Auliac, Jean-Bernard ; Westeel, Virginie ; Fallet, Vincent

BACKGROUND:

BRAF V600E mutations occur in 2-5 % of advanced non-small cell lung cancer (NSCLC) patients. The dabrafenib-trametinib (D-T) combination was associated with improved and durable OS in patients in phase II. This study (IFCT-2004 BLaDE study) reported the efficacy of D-T combination in a large retrospective French real-world multicenter cohort of patients with advanced BRAF V600E-mutated NSCLC.

METHOD:

Patients with advanced BRAF V600E-mutated NSCLC diagnosed between 01.01.2016 and 31.12.2019 and treated with D-T in combination, regardless of the treatment line, were included. The primary endpoint was the 12-month OS rate (%) in patients receiving D-T as a second-line therapy or beyond.

RESULTS:

A total of 163 patients were included: 50.3 % were female, 30.2 % were never smokers, 95.1 % had adenocarcinoma, and 78.2 % had a PDL1 ≥ 1 %. The median age was 68.3 years. At D-T initiation, 80.8 % of patients had a PS of 0/1, 78.6 % had stage IV disease, and 20.9 % had brain metastasis. At the cutoff, the median follow-up was 27.4 months. The 12-month OS rate in patients receiving D + T as a second-line therapy or beyond (n = 119) was 67.4 %, with a median progression-free survival (mPFS) of 10.4 months. Among the 44 patients who received D + T as a first-line therapy, the 12-month OS rate was 67.4 %, with an mPFS of 18.2 months. D-T discontinuation for toxicity was reported in 10.3 % of patients.

CONCLUSIONS:

To our knowledge, this is the largest retrospective cohort of BRAF-mutated patients reported. The findings confirmed the significant efficacy of D-T in combination with BRAF V600E-mutated metastatic NSCLC in pretreated and untreated patients. These results under real-world conditions are consistent with those of other registered studies.

58

News (Medical) associated with Dabrafenib Mesylate

27 Nov 2024

·endpts.com

Novartis to cut 139 jobs in NJ as part of commercial refocus

Novartis is laying off 139 employees in East Hanover, NJ, as the company shifts its commercial resources away from two “well-established” medicines. The layoffs will mainly affect members of the commercial field sales team who work on Novartis’ allergy and asthma medicine Xolair and its cancer treatment combining Tafinlar and Mekinist, a Novartis spokesperson said. Those drugs remain on the market, but the company says it’s pivoting its focus to a “new wave of innovation.” Novartis has announced ambitions to launch 15 new medicines or expanded labels over the next three years. It recently raised sales guidance through 2028, attributing the update in part to its transformation into a “pure-play” company. The new, leaner structure has allowed Novartis to focus on “the biggest opportunities that we have in the pipeline,” CEO Vas Narasimhan said last week at an investor event. Novartis said it completed a multi-year restructuring in 2023, though “additional streamlining” has led to cuts on the development side this year. On Novartis’ third-quarter earnings call with the media last month, Narasimhan said the company will always “be fine-tuning at a low level.” The cuts in East Hanover will occur between February and August of next year. Affected employees are encouraged to “apply for open positions in other areas of our business,” the Novartis spokesperson said. “As external factors continue to shift, our business priorities, capabilities and resource allocation must also evolve to ensure that we are best positioned to bring the next wave of innovation to patients in need,” the spokesperson said.

09 Aug 2024

·www.fda.gov

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors. The safety and efficacy were evaluated in 131 adult patients from open-label, multiple cohort trials BRF117019 (NCT02034110) and NCI-MATCH (NCT02465060), 36 pediatric patients from CTMT212X2101 (NCT02124772), and supported by results in COMBI-d, COMBI-v, and BRF113928 (studies in melanoma and lung cancer already described in product labeling). Study BRF117019 enrolled patients with BRAF V600E mutation positive specific solid tumors including high grade glioma (HGG), biliary tract cancer, low grade glioma (LGG), adenocarcinoma of small intestine, gastrointestinal stromal tumor, and anaplastic thyroid cancer (ATC). NCI-MATCH Subprotocol H enrolled adult patients with BRAF V600E mutation positive solid tumors except patients with melanoma, thyroid cancer, or CRC. Parts C and D of Study CTMT212X2101 enrolled 36 pediatric patients with BRAF V600 refractory or recurrent LGG or HGG. The major efficacy outcome measure of these studies was overall response rate (ORR) using standard response criteria. For the 131 adult patients, a total of 54 (41%, 95% CI: 33, 50) experienced an objective response. The studies enrolled patients with 24 tumor types, including different subtypes of LGG and HGG. Among the highest representative tumor types, ORR was 46% (95% CI: 31, 61) for biliary tract cancer, 33% (95% CI: 20, 48) for high grade glioma (combined) and 50% (95% CI: 23, 77) for low grade glioma (combined). For the 36 pediatric patients, the ORR was 25% (95% CI: 12, 42); DOR was ≥6 months for 78% of patients and ≥24 months for 44% of patients. The most common (≥20%) adverse reactions in adult patients were pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema. The most common (≥20%) adverse reactions in pediatric patients were pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia. The recommended dabrafenib dose in adult patients is 150 mg (two 75 mg capsules) orally twice daily in combination with trametinib 2 mg orally once daily. The recommended doses for dabrafenib and trametinib in pediatric patients are based on body weight. A recommended dose has not been established in patients who weigh less than 26 kg. View full prescribing information for Tafinlar and Mekinist This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer Content current as of: 06/23/2022 Regulated Product(s) Drugs 06/23/2022 Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

Priority ReviewAccelerated ApprovalDrug ApprovalClinical Result

09 Aug 2024

·www.fda.gov

FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

Skip to main content Skip to FDA Search Skip to in this section menu Skip to footer links Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description On March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills. This represents the first FDA approval of a systemic therapy for the first-line treatment of pediatric patients with LGG with a BRAF V600E mutation. View full prescribing information for Tafinlar and Mekinist. Efficacy was evaluated in Study CDRB436G2201 (NCT02684058), a multicenter, open-label trial in patients with LGG (WHO grades 1 and 2) requiring first systemic therapy. Patients were randomized 2:1 to dabrafenib plus trametinib (D+T) or carboplatin plus vincristine (C+V). BRAF mutation status was identified prospectively by local or central laboratory tests. Retrospective testing of available tumor samples by the central laboratory was also performed to evaluate mutation status. Patients received age- and weight-based dosing of D+T until they were no longer deriving benefit or experienced unacceptable toxicity. C+V were dosed based on body surface area at 175 mg/m2 and 1.5 mg/m2 (0.05 mg/kg for patients < 12 kg), respectively, as one 10-week induction course, followed by eight 6-week cycles of maintenance therapy. The major efficacy outcome measure was overall response rate (ORR) by independent review based on RANO LGG (2017) criteria. Additional efficacy outcome measures were progression- free survival (PFS) and overall survival (OS). The primary analysis was performed when all patients had completed at least 32 weeks of therapy. In the LGG cohort, 110 patients were randomized to D+T (n=73) or C+V (n=37). ORR was 46.6% (95% CI: 34.8, 58.6) in the D+T arm and 10.8% (95% CI: 3.0, 25.4) for those receiving C+V (p= <0.001). DOR was 23.7 months (95% CI: 14.5, not estimable) in the D+T arm and not estimable (95% CI: 6.6, not estimable) in the C+V arm. PFS was 20.1 months (95% CI: 12.8, not estimable) and 7.4 months (95% CI: 3.6, 11.8) (HR=0.31 [95% CI: 0.17, 0.55]; p= <0.001) in the D+T and C+V arms, respectively. At the time of the interim analysis of OS conducted when all patients had completed at least 32 weeks of treatment or had discontinued earlier, there was one death on the C+V arm. The OS results at the interim analysis did not reach statistical significance. In the pooled safety population of pediatric patients receiving D+T (N=166), the most common (>20%) adverse reactions were pyrexia (66%), rash (54%), headache (40%), vomiting (38%), musculoskeletal pain (36%), fatigue (31%), dry skin (31%), diarrhea (30%), nausea (26%), epistaxis and other bleeding events (25%), abdominal pain (24%), and dermatitis acneiform (23%). The most common (>2%) Grade 3 or 4 laboratory abnormalities were decreased neutrophil count (20%), increased alanine aminotransferase (3.1%), and aspartate aminotransferase increased (3.1%). The recommended doses for dabrafenib and trametinib in pediatric patients are based on body weight; dabrafenib is administered orally twice daily and trametinib is administered orally once daily. Dabrafenib and trametinib are administered until disease progression or unacceptable toxicity. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Israel’s Ministry of Health and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review, breakthrough designation and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer. Content current as of: 03/31/2023 Regulated Product(s) Drugs Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

Drug ApprovalAccelerated ApprovalPriority ReviewClinical ResultBreakthrough Therapy

100 Deals associated with Dabrafenib Mesylate

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KEGG	Wiki	ATC	Drug Bank
D10104	Dabrafenib Mesylate	L01XE23	DB08912

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
BRAF mutation positive hairy cell leukemia	JP	Novartis Pharma AG	24 Nov 2023
BRAF mutation Solid Tumors	JP	Novartis Pharma AG	24 Nov 2023
High grade glioma	EU	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	IS	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	LI	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	NO	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	EU	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	IS	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	LI	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	NO	Novartis Europharm Ltd.	15 Nov 2023
BRAF V600E mutation-positive low grade glioma	US	Novartis Pharmaceuticals Corp.	16 Mar 2023
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer	US	Novartis Pharmaceuticals Corp.	04 May 2018
BRAF Mutation Non-small Cell Lung Cancer	JP	Novartis Pharma AG	28 Mar 2016
BRAF mutation positive Melanoma	JP	Novartis Pharma AG	28 Mar 2016
BRAF V600E mutant Non-small Cell Lung Cancer	KR	Novartis Korea Ltd.	25 Sep 2014
BRAF V600E Mutation-Positive Solid Tumors	KR	Novartis Korea Ltd.	25 Sep 2014
BRAF V600K Mutation-Positive Melanoma	US	Novartis Pharmaceuticals Corp.	09 Jan 2014
Melanoma	AU	Novartis AG	27 Aug 2013
BRAF V600 mutation-positive Melanoma	EU	Novartis Europharm Ltd.	26 Aug 2013
BRAF V600 mutation-positive Melanoma	IS	Novartis Europharm Ltd.	26 Aug 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Differentiated Thyroid Gland Carcinoma	Phase 3	US	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	CN	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	CN	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	AR	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	AR	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	BR	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	BR	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	CA	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	CA	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	IN	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01682083 (COMBI-AD, Pubmed \| N Engl J Med)	Phase 3	Melanoma Adjuvant	870	Dabrafenib plus Trametinib	ynjjmjvizq(plolkexxry) = the benefit was not significant ffmgdkkown (tatdzclftt ) View more	Positive	07 Nov 2024
				Placebo
EURETINA2024	Not Applicable	Histiocytosis, Langerhans-Cell	-	Vemurafenib	oaevklcney(uvabeudmdg) = VKH-like syndrome secondary to dabrafenib lfzrkfrqqp (mqvsssurct ) View more	-	19 Sep 2024
ESMO2024 Manual	Not Applicable	Differentiated Thyroid Gland Carcinoma Second line \| First line BRAFV600E mutation	37	Dabrafenib trametinibinib (D+T)	ksdlwybeub(xgvkykabqb) = foklecpftr wablcrjipg (ggufdglabz, 49.2 - 95.3) View more	Positive	16 Sep 2024
				Dabrafenib+trametinib (≥ 2nd line)	ksdlwybeub(xgvkykabqb) = nppzdsqjsx wablcrjipg (ggufdglabz, 16.3 - 61.6) View more
ESMO2024 Manual	Not Applicable	Recurrent Glioblastoma BRAF V600E	17	Dabrafenib-trametinib	blixvafayy(eldrtenyoq) = None fpoxiulziu (ryzjwmjzgi )	Positive	16 Sep 2024
				Larotrectinib
NCT03944356 (COMBI-EU, ESMO2024)	Not Applicable	BRAF V600 mutation-positive Melanoma Adjuvant	225	Adjuvant dabrafenib plus trametinib (D+T)	kgoqcadizq(gmxtrknzdz) = pyrexia being the most common (38.2%) hamwtluilb (awhksiwozw ) View more	Positive	14 Sep 2024
				dabrafenib (High-level AE management)
NCT04527549 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Unresectable Melanoma \| Locally Advanced Melanoma	5	Dabrafenib mesylate+Hydroxychloroquine+Trametinib dimethyl sulfoxide (Arm A (Dabrafenib, Trametinib, Hydroxychloroquine))	fgtwfopmej(aqgwriulsl) = kcfusmjhot ekusfgycrq (lcbxwcfsuh, ijdknosrwa - qomgcjtbzy) View more	-	22 Aug 2024
				Placebo Administration+Dabrafenib mesylate+Trametinib dimethyl sulfoxide (Arm B (Dabrafenib, Trametinib, Placebo))	fgtwfopmej(aqgwriulsl) = sknqkptwsw ekusfgycrq (lcbxwcfsuh, biubvchwzo - eaextbkqoq) View more
NCT01682083 \| EUCTR2012-001266-15-NO (COMBI-AD, Literature) Manual	Phase 3	Melanoma	870	Dabrafenib plus Trametinib	exkrexuucd(grfobdagfi): HR = 0.80 (95% CI, 0.62 - 1.01), P-Value = 0.06 View more	Positive	19 Jun 2024
				Placebo
NCT01682083 (COMBI-AD, ASCO2024) Manual	Phase 3	BRAF mutation positive Melanoma Adjuvant BRAF V600E	-	Dabrafenib plus trametinib	pbtnexdymi(xaspmuzqyk) = qdoyqgiifz apusuoyixl (vbmqcfsavb ) View more	Positive	24 May 2024
				Placebo	pbtnexdymi(xaspmuzqyk) = hpnupajhkq apusuoyixl (vbmqcfsavb ) View more
NCT02684058 (ASCO2024)	Phase 2	BRAF V600 mutation low-grade glioma First line BRAFV600E mutations	-	Dabrafenib+Trametinib	dafmmqcusk(gtqlpowtbz) = The resulting ICER was $1,526,265 per QALY gained apcrhyxxmf (qvqmxqnzws ) View more	Negative	24 May 2024
				Standard chemotherapy
GOIRC-03-2020 \| LiBRA (ESMO_ELCC2024) Manual	Not Applicable	BRAF V600E mutant Non-small Cell Lung Cancer First line BRAF V600E \| TP53	41	Dabrafenib pltrametinibnib (D+T)	llejpqpvga(iyfxgjkpiv) = dcmdohxqsu txaloqakdo (kumaggbmaj, 16.5 - NR) View more	Positive	22 Mar 2024