AstraZeneca CTLA-4 Inhibitor Imjudo (Finally) Wins FDA Approval
Pharma To Carve HCC Niche On Survival Data
More than a decade after Pfizer gave up on it, tremelimumab won approval combined with PD-L1 inhibitor Imfinzi for frontline hepatocellular carcinoma, ahead of Bristol’s Yervoy/Opdivo second-line indication.
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Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.
Now approved for the treatment as well as the prevention of COVID-19 in the EU and Japan, the UK major’s antibody combo passed the $500m sales barrier in the third quarter and CEO Pascal Soriot is confident that growth will continue.
Keeping Track: AZ’s Imjudo, J&J’s Tecvayli Enter Burgeoning Immuno-Oncology Market; Genmab Submits Epcoritamab
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker