New drug application approved by US FDA as of 16 - 31 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.
The oral multikinase VEGFR*1, 2, and 3 inhibitor pazopanib failed to improve overall survival (OS) in advanced ovarian cancer patients who have not progressed following first-line chemotherapy, according to the results of the AGO-OVAR16** study.
The combination of gemcitabine plus S-1 (GS) is as good as gemcitabine plus cisplatin (GC), the current standard treatment for advanced biliary tract cancer (BTC), according to data from the phase III FUGA-BT trial (JCOG1113). However, the former does not require concomitant hydration therapy and should be considered a new treatment option for patients with advanced or recurrent BTC.
According to the results of a systematic review and network meta-analysis, osimertinib and gefitinib plus pemetrexed-based chemotherapy appear to be the best first-line treatments, as shown by their most favourable progression-free (PFS) and overall survival (OS), for patients with advanced epidermal growth factor receptor (EGFR)-mutated nonsmall cell lung cancer (NSCLC).
The efficacy and safety of the biosimilar IBI303 mirrored that of the monoclonal anti-TNFα* antibody adalimumab, thus providing a new and affordable treatment alternative for individuals with ankylosing spondylitis, according to a Chinese study.
The incidence of urolithiasis (kidney/renal stones) depends on geographic, climatic, ethnic, dietary, and genetic factors. Assistant Professor Chua Wei Jin, Senior Consultant, Department of Urology at the National University Hospital in Singapore discusses with Audrey Abella why urolithiasis is an important healthcare problem that requires attention.
In older adults with systolic hypertension, targeting a 24-hour ambulatory systolic blood pressure (BP) of ≤130 vs ≤145 mm Hg does not appear to be beneficial in terms of mobility outcomes during a 3-year period, although it yields a favourable effect on subcortical white matter disease, according to data from the INFINITY trial.
Adding the PD-L1 inhibitor atezolizumab to first-line platinum-based chemotherapy significantly prolonged progression-free survival (PFS) compared with chemotherapy alone in patients with metastatic urothelial carcinoma (mUC), according to the IMvigor130* study presented at the ESMO Congress 2019.
A once-weekly exenatide regimen is safe and well tolerated in diabetic patients with or without heart failure (HF), although its beneficial effects on all-cause death and first HF hospitalization appear to be weakened in those without HF at baseline, according to the results of the EXSCEL* trial.
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
Use of direct acting antivirals (DAAs) to treat hepatitis C virus (HCV) infection is feasible during pregnancy, as these drugs are highly effective and treatment duration is relatively short, according to a study. In addition, DAA treatment helps improve maternal health and prevent vertical transmission.
The addition of pertuzumab to a trastuzumab-docetaxel regimen in the neoadjuvant setting improved total pathological complete response (tpCR) rates in Asian women with early or locally advanced ERBB2-positive breast cancer, according to the phase III PEONY trial from China.
Use of menopausal hormone therapy (MHT) was associated with a significantly increased risk of invasive breast cancer, which became progressively greater with longer duration of use, a meta-analysis of worldwide prospective epidemiological studies has shown.