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
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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.
No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.
Genmab may only recently have launched its first commercial operations with Tivdak, but is stepping up to co-market epcoritamab with AbbVie against the might of Roche in the new CD20xCD3 field.