Melanoma is a skin neoplasm that originates from malignant transformation of melanocytes.
It commonly occurs in the extremities of women and on trunk or head and neck in men.
Metastases are via lymphatic and hematogenous routes.
A complete response to dabrafenib and trametinib treatment in patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations leads to greater survival outcomes at 5 years, according to an analysis of data from the COMBI-d* and COMBI-v** trials.
Patients with advanced, unresectable melanoma may derive overall survival (OS) and progression-free survival (PFS) benefits when treated with a nivolumab plus ipilimumab combination or nivolumab alone, according to 4-year results of the phase III CheckMate 067* trial presented at ESMO 2018.
The FDA approval and subsequent use of checkpoint blockade immunotherapy (CBI) and BRAFV600 targeted therapy almost doubled the overall survival (OS) in patients with stage 4 melanoma with brain metastases (MBM), according to a recent US-based study.
Pembrolizumab delivered intravenously every 3 weeks for 1 year extended recurrence-free survival (RFS) in patients with resected stage III melanoma, according to results of the KEYNOTE-054/EORTC 1325-MG* trial.
Dermoscopy plus conventional and modified clinical ABCD criteria (amelanotic, bleeding bump, colour uniformity, de novo at any diameter) improves diagnosis of paediatric melanoma (PM), suggests a recent study. Dermoscopy helps in differentiating spitzoid from nonspitzoid melanomas.
Individuals with advanced melanoma treated with pembrolizumab had better overall survival (OS) compared with those treated with ipilimumab regardless of pembrolizumab dosing schedule, results of the final survival analysis of the KEYNOTE-006* trial showed.
New drug applications approved by US FDA as of 01 - 15 October 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.