Posts

Pembrolizumab and atezolizumab USPIs updated by FDA

On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.

us-fda-approval-medipaper-medical-communications-agency-medical-writer-agency-apac-asia-pacific-HK-hong-kong-oncology-CV-neurology-immunotherapy-obesity-diabetes-specialty-infectious.jpg

Pembrolizumab approved for advanced gastric cancer

On September 22, 2017, the FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for use in patients with locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for PD-L1 as determined by an FDA-approved companion diagnostic (CDx) and progressing after ≥2 prior systemic therapies, including a fluoropyrimidine- and platinum-containing regimen, and, when appropriate, HER2-targeted therapy.