EMA validates application for BMS’s Opdivo + Yervoy for unresectable or advanced HCC

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The European Medicines Agency validated Bristol Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy. 

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Devanand Sarkar and a team of scientists at VCU Massey Comprehensive Cancer Center have discovered that the gene TAF2 plays a pivotal role in the growth of hepatocellular carcinoma. The researchers found that TAF2 is overexpressed in HCC patients compared to individuals with healthy livers, and that TAF2 regulates the survival of hepatocytes—the functional cells of the liver—and tumor formation. Their study—recently published in the journal Hepatology also demonstrates that TAF2 cooperates with the MYC gene, another known major driver of cancer, to accelerate tumor growth.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) from Bristol Myers Squibb for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma, based on results from the phase III CheckMate-9DW trial. The CHMP opinion will now be reviewed by the European Commission.

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