New drug applications approved by US FDA as of 16-31 March 2021 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.
A minimal monitoring (MINMON) approach to treatment of hepatitis C virus (HCV) infection with sofosbuvir/velpatasvir appeared to render an acceptable sustained virological response (SVR), according to results of the phase IV ACTG* A5360 trial.
Longer-term follow-up after the final analysis of the KEYNOTE-240* trial showed that improvements in overall survival (OS) and progression-free survival (PFS) with pembrolizumabwere maintained in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib, according to updated results of the trial presented at ASCO GI 2021.
Results of a single-centre study in the UK have suggested that patients receiving systemic anticancer therapy for gastrointestinal (GI) cancers could continue their treatment during the COVID-19 pandemic.
Unrestricted access to direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infection in individuals with HIV led to a substantial reduction in HCV incidence, particularly in the key subgroup of men who have sex with men (MSM), according to a retrospective Dutch study.
Switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) did not result in worsening renal function or bone mineral density (BMD) in Asian patients with chronic hepatitis B virus (HBV) infection, according to a small real-world prospective study.
Infigratinib may be a suitable second- or later-line treatment option for patients with advanced or metastatic cholangiocarcinoma (CCA) with FGFR2* fusions or rearrangements, according to interim results of a phase II, open-label, single-arm study presented at ASCO GI 2021.