A newly published cache of CRLs includes six novel oncology drugs.
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The deal for ISB 2001 is worth $700m up front.
An accelerated approval looks off the table, as the group’s first-line melanoma trial continues.
The NMPA has refused to back PFS, plus subgroup OS analyses, in fruquintinib’s stomach cancer study.
Duelling pivotal trials of anti-TROP2 ADCs should yield their first data imminently.
A US adcom will next month try to unravel confusion about PD-L1 status in first-line gastric cancer.
It’s back to school for biotech, with a packed conference schedule.
Other new first-in-human trials involve CD74, where Gilead and Sutro tried and failed, and the emerging target MAT2A.