Amol Akhade, Consultant Medical Oncologist at Suyog Cancer Clinics, shared a post on X:
“FDA grants accelerated approval to Dato-DXd for EGFR-mutated NSCLC post-TKI plus chemo
But what’s the full picture?
Based on 117 patients pooled from TROPION-Lung01 and Lung05
ORR: 43%
PFS: 5.8 mo
OS: 15.6 mo
Prior osimertinib in 82% of patients
Common tox:
Stomatitis (69% any grade)
Ocular events (32%)
ILD (4%)
Signal of activity in a high-need population
But:
No control arm
No stratification by TROP2 or EGFR mutation subtype
Limited CNS data
Accelerated based on surrogate endpoints (ORR/DOR)
Dato-DXd brings hope, but confirmatory data is essential.
A step forward – but we must walk with scientific caution.”
More posts featuring Amol Akhade.