Posts

Ipilimumab plus nivolumab FDA approved for MSI-H and dMMR pre-treated mCRC

On July 10th, the FDA granted accelerated approval to ipilimumab (Yervoy©, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo©) for the treatment of adult and paediatric patients ≥12 years of age with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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, HER2targeted therapy.