A Narrow FDA Approval illustration

A Narrow FDA Approval

The FDA approved Jemperli for some adults with previously untreated stage II or III locally advanced rectal cancer.

Tumor Tests Matter

Eligibility also requires dMMR or MSI-H tumor characteristics, confirmed with an FDA-authorized test.

What The Terms Mean

These markers reflect problems repairing DNA-copying errors, which can produce proteins the immune system recognizes.

How Jemperli Acts

Jemperli blocks PD-1, a protein on immune cells, helping them act against cancer cells that use shielding signals.

Study Results Remain Early

In AZUR-1, almost three-fourths of 154 participants had not needed surgery, radiation, or chemotherapy after median follow-up exceeding two years.

Longer Follow-Up Is Needed

Interim findings cannot show how long responses last or how often cancer returns; continued patient monitoring is required.

Risks And Common Effects

Jemperli may cause severe or fatal immune attacks on healthy tissues; fatigue, rash, diarrhea, and itching were common.

Read More About Approval

Explore the FDA announcement for eligibility details, trial findings, safety information, and the approval’s remaining uncertainties.

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