FDA green and red lights: Q1 2024
A roundup of the first quarter's key oncology drug approvals and rejections.
Nuvation takes the battle to Nuvalent
The takeover of AnHeart centres on advancing the latter’s targeted lung cancer project taletrectinib.
Yervoy delivers a surprise in liver cancer
Checkmate-9DW scores a topline win on overall survival, when failure seemed more likely.
A panel of two halves for multiple myeloma Car-Ts
Carvykti sailed through Friday’s adcom, but Abecma got a much rougher ride.
FDA critics barely lay a glove on Geron
Imetelstat appears headed for approval after its US adcom turns into a damp squib.
Multiple myeloma Car-Ts face a US grilling
The FDA highlights high death rates and questions overall survival for Carvykti and Abecma.
Seven problems for Geron
Brutal FDA briefing documents raise questions about the approvability of imetelstat for myelodysplastic syndromes.
Deals mask CytomX’s fundamental problem
Another disappointment raises fresh doubts about CytomX’s extensively partnered masked therapeutics.
