Amol Akhade/LinkedIn
Jun 24, 2025, 09:20
Amol Akhade: FDA Grants Accelerated Approval to Dato-DXd for EGFR-mutated NSCLC Post-TKI Plus Chemo
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.
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Challenging the Status Quo in Colorectal Cancer 2024
December 6-8, 2024
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ESMO 2024 Congress
September 13-17, 2024
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ASCO Annual Meeting
May 30 - June 4, 2024
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Yvonne Award 2024
May 31, 2024
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OncoThon 2024, Online
Feb. 15, 2024
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Global Summit on War & Cancer 2023, Online
Dec. 14-16, 2023
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