1. Trastuzumab deruxtecan granted FDA priority review to treat patients with HER2-positive metastatic breast cancer
AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted priority review. more details...


2. FDA Approves Cyramza for Liver Cancer Treatment
The Food and Drug Administration (FDA) approved Cyramza (ramucirumab) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) with an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with Nexavar (sorafenib), according to the FDA.more details...


3. Lilly's CYRAMZA® (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma
This new indication - the fifth FDA approval for CYRAMZA in an advanced or metastatic cancer - is for the second-line treatment of patients with hepatocellular carcinoma (HCC) who are AFP-High (AFP ≥400 ng/mL) Approximately forty percent of all patients with advanced HCC are AFP-High and are a patient population that can have more aggressive disease and a poorer prognosis Concurrent with this approval, the FDA has also removed the boxed warning from the CYRAMZA labeling more details...