HCC

Latest News


Latest Videos


CME Content


More News

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

In the community practice setting, patients with hepatocellular carcinoma who receive systemic therapy have a poor prognosis, which reveals an unmet need for more effective treatment options, according to a real-world retrospective observational study. The study aimed to show how treatment patterns related to the overall survival of patients with HCC throughout the United States.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Better rates of overall survival were observed in patients with intermediate-stage hepatocellular carcinoma who had an elevated baseline alpha-fetoprotein level when ramucirumab was used as second-line therapy after sorafenib compared with second-line placebo. These improvements occurred irrespective of patients' Barcelona Clinic Liver Cancer stage and were based on results of a pooled analysis of the phase III REACH and REACH-2 trials