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FDA approves dostarlimab for rectal cancer

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The US FDA granted accelerated approval to dostarlimab (Jemperli) on 19 October 2026 for adults with certain locally advanced rectal cancers.

Key points

  • The US FDA granted accelerated approval to dostarlimab (Jemperli, GSK) on 19 October 2026.
  • It applies to adults with stage II or III locally advanced rectal cancer that is dMMR or MSI-H.
  • The approval rests on interim results from a single-arm, open-label study called AZUR-1.
  • This is a US decision; UK availability is decided separately.

What was announced

On 19 October 2026 the US Food and Drug Administration (FDA) granted accelerated approval to dostarlimab (Jemperli, GSK).

It is approved for adults with stage II or III locally advanced rectal cancer whose tumours are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

The FDA says it acted four months ahead of its goal date, and that the drug had earlier received breakthrough therapy designation.

What it means

The FDA says the approval relied on interim results from AZUR-1, a single-arm, open-label study in patients with previously untreated dMMR or MSI-H locally advanced rectal cancer.

Because the approval is accelerated, the sponsor must keep following patients to confirm lasting benefit.

This is a US decision; availability in the UK is decided separately by the MHRA and NICE.

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