US rejects MSD/Eisai’s Keytruda Lenvima combo
Regulators rejected accelerated approval as Roche’s combination for the same patient population made it over the line first
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Tag: HCC
Roche’s Tecentriq/Avastin combo wins US approval
Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen cleared to treat unresectable or metastatic liver cancer
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Vemlidy tackles hep B in late-stage trials
The impact of chronic hepatitis B treatment on hepatocellular carcinoma incidence was evaluated in a long-term analysis of the Gilead drug.
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Promising early results for BMS’ investigational HCC study
The company are “encouraged by these early results”, as liver cancer affects over 5,700 new patients in the UK each year.
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Bayer’s Stivarga wins NICE backing for advanced liver cancer
Bayer’s Stivarga has been recommended for use on the NHS by the National Institute for Health and Care Excellence (NICE) following a rapid review of guidance published earlier in the year.
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Ipsen’s Cabometyx wins EU nod for liver cancer
Ipsen’s Cabometyx can now be used as monotherapy to treat certain patients with liver cancer following a green light from regulators in Europe.
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Cabometyx trial halted early on success in liver cancer
A late-stage trial assessing Ipsen and Exelixis’ Cabometyx in advanced liver cancer has been halted early after a significant improvement in overall survival was observed.
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US, EU filings for Eisai’s lenvatinib in liver cancer
Eisai has filed its anticancer drug lenvatinib for liver cancer on both sides of the Atlantic as it seeks to expand the drug’s list of approved uses.
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Priority review for BMS’ Opdivo in liver cancer
US regulators will undertake a speedy review of Bristol-Myers Squibb’s application to expand use of its immunotherapy Opdivo to include to include certain patients with liver cancer.
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Eisai’s Lenvima hits liver cancer targets in PhIII trial
A late-stage trial assessing Eisai’s cancer drug Lenvima for hepatocellular carcinoma (HCC) has achieved its primary endpoint, pushing the drug closer to being filed for approval in this setting.
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Priority review in the US for Bayer’s liver cancer drug
US regulators will undertake a speedy review of Bayer’s application to expand the reach of its cancer drug regorafenib to include the second-line treatment of patients with unresectable hepatocellular carcinoma (uHCC).
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Bayer files for expanded use of Stivarga in liver cancer
Bayer has filed applications in Europe, the US and Japan seeking approval to expand the scope of its cancer drug regorafenib to include the second-line treatment of liver cancer.
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- Laigo Bio completes final close of €17m seed financing round
- Axplora announces expansion as newest part of $60m API investment programme
- DNA Script signs SYNTAX distribution agreements with Gencell, BMS and Biostream
- Ondine’s Steriwave phase 3 trial reaches 93% enrolment milestone
- Arvinas reports strong phase 1 results for ARV-102 in Parkinson’s disease
