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U.S. FDA approved immunecheckpoint inhibitors U.S. FDA approved immunotherapies for cancer U.S. FDA approved immunotherapies for cancer

US FDA approved immune-checkpoint inhibitors updated 11-Dec-2018

Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

ESMO 2018 HCC ESMO18 Liver Cancer ESMO2018 hepatocellular carcinoma hepatobiliary cholangiocarcinoma BTC

ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised

Whereas this year’s American Society of Clinical Oncology Annual Meeting (ASCO 2018) boasted two Phase III studies and four Phase II studies with notable results in hepatocellular carcinoma (HCC), the trend did not continue to the European Society for Medical Oncology Conference (ESMO 2018), held in Münich, Germany between October 19-23, 2018. The focus for this years ESMO was mostly on biliary-tract cancers (BTC). Welcome to the hepatobiliary track of ESMO 2018.

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.

EBV, MSI, and CPS predict pembrolizumab outcome in gastric cancer

Metastatic gastric cancer (mGC) patients with microsatellite instability-high (MSI-H) or Epstein-Barr virus (EBV)-positive tumours, or those with a positive (≥1%) combined positive score (CPS) respond best to pembrolizumab PD-1 immunotherapy.

FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1 

 

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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.