FDA green and red lights: July 2024
Darzalex added another string to its bow, while Kisqali’s early use has been delayed.
Aegean in the clear
But Imfinzi's precise setting is uncertain, and big problems loom for companies pursuing similar trials.
FDA sends a warning about perioperative cancer studies
An adcom on Imfinzi’s Aegean trial will show whether neoadjuvant and adjuvant benefits must be split out.
A second-line degrader battle beckons
Readouts for Lilly and Pfizer/Arvinas loom, but many SERD hopefuls are now focused on earlier-stage breast cancer.
Apollomics shifts to a smaller niche
The group abandons plans in lung cancer with Met exon 14 skipping, to focus on Met amplifications.
