Maria Babak, Head of The Babak Lab and Assistant Professor at City University of Hong Kong, shared a post by The Babak Lab, adding:
“40% reduction in risk of death – remarkable.”
Quoting The Babak Lab‘s post:
“Clinical Mondays: FDA Approves Tarlatamab‑dlle for ES‑SCLC
The FDA has granted traditional approval to tarlatamab‑dlle (Imdelltra), a bispecific T‑cell engager (BiTE), for adults with extensive‑stage small cell lung cancer (ES‑SCLC) that has progressed after platinum‑based chemotherapy.
Key Focus
This approval focuses on addressing treatment gaps in ES‑SCLC through a novel bispecific T‑cell engager targeting DLL3. It marks a move from accelerated to full FDA approval, providing a new standard of care after first-line chemotherapy failure.
Key Insights
- Bispecific T‑cell engagers bring immune cells directly to cancer cells by binding both DLL3 and CD3
- Phase III trial results showed meaningful clinical benefit over current chemotherapy options
- Represents the first DLL3‑targeting therapy to gain full regulatory approval
Conclusion
Tarlatamab‑dlle (Imdelltra) sets a new benchmark in second‑line treatment of ES‑SCLC. With its targeted action and improved survival outcomes, it reinforces the growing potential of BiTE therapies in hard‑to‑treat cancers.
What do you think? How might BiTE therapies reshape the treatment landscape for “cold” tumours over the next 5 years?
Image generated using Sora by OpenAI.
The link to the full article.”

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