RE:RE:Antibody-Drug Conjugate (ADC) developments September 23, 2023 - AstraZeneca, Daiichi’s Enhertu successor faces more questions after latest stumble
The partners said their antibody-drug conjugate datopotomab deruxtecan didn’t extend survival in a breast cancer study, fueling doubts about its approval prospects.
But the future of datopotomab deruxtecan, or dato-dxd for short, is now unclear. In lung cancer, it similarly delayed disease progression in a Phase 3 trial, but didn't extend survival, even among those who had been expected to benefit the most from treatment. That result, which was disclosed earlier this month, led analysts at the investment bank Stifel to speculate that the FDA might delay an approval decision and convene a panel of outside advisers.
Dato-dxd could now face a more complex path to market in breast cancer too. Overall survival was one of the two main goals of its breast cancer trial and is the FDA’s gold standard for the approval of a cancer drug.