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.
The risk of serious infection* among patients receiving systemic therapy for psoriasis differs by treatment, with apremilast, etanercept, and ustekinumab associated with a reduced risk of serious infection than methotrexate, according to an observational study.
The anti-interleukin (IL)-23p19 monoclonal antibody tildrakizumab showed better efficacy over placebo, along with a favourable safety profile, in patients with active psoriatic arthritis (PsA), according to a phase IIb study presented at EULAR 2019.
Adjuvant treatment with ipilimumab significantly improved overall survival (OS) among patients with resected high-risk melanoma compared with high-dose interferon-α2b (HDI*), according to final results of the North American Intergroup E1609** trial presented at ASCO 2019.
Treatment with the tyrosine kinase inhibitor (TKI) nintedanib reduces pulmonary function decline in patients with systemic sclerosis–associated interstitial lung disease (SSc-ILD), according to the phase III SENSCIS* trial which is touted as the largest randomized controlled trial in SSc-ILD thus far.
New drug applications approved by US FDA as of 16 - 30 April 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.