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Update 4 June 2026

Tarlatamab

Lung – SCLC / Extensive-Stage

Québec / Canada

10 mos.

positive 20 October 2023

Clinical Trials

7 mos.

restricted 11 September 2024

Health Canada

negative 30 April 2025

INESSS (QC)

in-progress

pCODR (CA)

pCPA

RAMQ / LM

Comparison with other countries

United States

United States

positive 16 May 2024

FDA approval

Europe

Europe

in-progress

EMA approval

Canada

Canada

in-progress

Health Canada

Tarlatamab was granted accelerated approval from the FDA on May 16, 2024 and has designated by the EMA as an orphan medicine in January 2024 for the treatment of SCLC.

Tarlatamab received conditional approval from Health Canada on September 11, 2024. The indication is for patients on third line. (Rechallenge with EP is counted as a second line)

Treatment is accessible through a PSP, the drug is commercially available in Canada as of December 2nd 2024.

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