FDA green and red lights: Q1 2024
A roundup of the first quarter's key oncology drug approvals and rejections.
FDA knocks back Regeneron’s CD20 T-cell engager
The decision highlights the fact that Regeneron is still doing dose-finding work for odronextamab.
Immutep approaches Lag3 crunch time
Results with eftilagimod alpha in first-line head and neck cancer threaten to cloud partnering prospects.
Deals mask CytomX’s fundamental problem
Another disappointment raises fresh doubts about CytomX’s extensively partnered masked therapeutics.
The new normal in US oncology approvals
Nearly two thirds of key oncology filings are expedited; and what about the ones that aren’t?
Make or break time for Iovance
Lifileucel heads up the list of upcoming US FDA catalysts.
Regeneron works to secure fianlimab
A just revealed phase 3 trial will apparently pit a fixed-dose combo head to head against Opdualag.
Merck’s conjugates dominate pivotal trial initiations
Raludotatug deruxtecan, ABBV-383 and zongertinib advance into phase 3, while other pivotal programmes are expanded.
Another setback for Opdualag's post-melanoma plan
The latest failure, in colorectal cancer, follows a recent disappointment in second-line liver.
