FDA Denies Accelerated Approval of Keytruda Plus Lenvima for Unresectable HCC
In the CRL, the FDA stated that the data from KEYNOTE-524/Study 116 did not demonstrate a meaningful advantage over available therapies for unresectable or metastatic HCC.
Diagnosis & Disease Information
Keytruda Approved as First-Line Treatment of MSI-H or dMMR Colorectal Cancer
The FDA has approved Keytruda (pembrolizumab; Merck), a programmed death receptor-1 -blocking antibody, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Opdivo Approved for Advanced Esophageal Squamous Cell Carcinoma
The FDA has approved Opdivo® (nivolumab; Bristol Myers Squibb) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Ready-to-Dilute Liquid Formulation of Akynzeo Injection Approved
The FDA has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.
Immunotherapy Regimen Approved for Hepatocellular Carcinoma
The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Pediatric Inflammatory Bowel Disease Associated With Increased Risk for Cancer, Mortality
Researchers conducted a retrospective study of pediatric patients with inflammatory bowel disease to estimate the risk for cancer and mortality associated with this diagnosis.
Cyramza Approved to Treat Hepatocellular Carcinoma
The FDA has approved Cyramza (ramucirumab; Lilly) for use as a single agent in the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400ng/mL and have been treated with sorafenib.
Picture Forum: Ovarian cancer Guidelines ignore ‘key symptom’
Ovarian cancer cases are being missed because diagnosis guidelines do not mention abdominal distension, the symptom most likely to be associated with the cancer, a study suggests.
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