FDA green and red lights: June 2024
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
Merck and Daiichi’s first ADC attempt is knocked back, while Geron gets its inaugural approval.
The EU recommendation for odronextamab comes after a US rejection in March.
Farletuzumab ecteribulin follows its parent MAb with a setback, spelling possible bad news for Sutro.
But ficerafusp is limited to HPV-negative disease, and petosemtamab’s safety looks better.
Predictably Tacti-003 fails, but funding is secured – from investors, not a partner.
A complete response letter for Merck & Co and Daiichi’s patritumab deruxtecan might not be fatal, but it’s certainly embarrassing.
The group plays down upcoming interim analysis, but still hopes for accelerated approval.
The ROR1 data are sketchy, and lung toxicity clouds prospects.
A second Lilly Nectin-4 ADC features among the latest phase 1 initiations.
One of the German group’s biggest cancer hopes has fallen flat, raising more questions about targeting an apoptosis pathway.