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Naporafenib

Alternative Names: naporafenib, lxh-254, lxh254, lxh 254
Latest Update: 2024-12-19
Latest Update Note: Clinical Trial Update

Product Description

Naporafenib (LXH254) is an investigational, potent, selective and orally bioavailable RAF inhibitor that was designed to target RAS mutant cancers,i.e.those that harbour genetic alterations in the RAS-RAF-MEK-ERK (MAPK) pathway

Mechanisms of Action: BRAF Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Fast Track - Melanoma *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Naporafenib

Countries in Clinic: Argentina, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Israel, Italy, Korea, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States

Active Clinical Trial Count: 4

Highest Development Phases

Phase 3: Melanoma

Phase 1: Central Nervous System Cancer|Colorectal Cancer|Non-Small-Cell Lung Cancer|Pancreatic Cancer|Sarcoma|Thyroid Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
ERAS-254-02

P3

Unknown Status

Melanoma

2028-07-30

SEACRAFT-2

P3

Recruiting

Melanoma

2028-04-01

SEACRAFT-1

P1

Recruiting

Pancreatic Cancer|Sarcoma|Central Nervous System Cancer|Melanoma|Colorectal Cancer|Thyroid Cancer|Non-Small-Cell Lung Cancer

2025-07-01

CLXH254C12201

P2

Active, not recruiting

Melanoma

2024-11-29

Recent News Events

Date

Type

Title

10/24/2024

News Article

 Erasca Announces Strong Momentum for Naporafenib and RAS Targeting Franchise

09/25/2024

News Article

 Erasca to Present Preliminary SEACRAFT-1 Phase 1 Data for Naporafenib Plus Trametinib in RAS Q61X Mutant Solid Tumors as Oral Presentation at 36th EORTC-NCI-AACR Symposium

06/18/2024

News Article

 Erasca Initiates SEACRAFT-2 Pivotal Phase 3 Trial Evaluating Naporafenib Plus Trametinib in Patients with NRAS-Mutant Melanoma

04/24/2024

News Article

 Erasca Announces Three Presentations at the 2024 ASCO Annual Meeting

01/01/2024

PubMed

 First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations.

11/16/2023

PubMed

 Protomer selectivity of type II RAF inhibitors within the RAS/RAF complex.

09/01/2023

PubMed

 BRAFΔβ3-αC in-frame deletion mutants differ in their dimerization propensity, HSP90 dependence, and druggability.

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