FDA approves Jemperli for advanced rectal cancer subtype

The U.S. Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) for the treatment of advanced rectal cancer with specific genetic characteristics. This immunotherapy, developed by GSK plc, is the first of its kind to receive authorization for this indication. The approval, achieved through an accelerated pathway, is based on data from the phase II AZUR-1 trial.

The condition targets approximately 5-10% of rectal cancer cases and is characterized by microsatellite instability-high or mismatch repair deficiency. The AZUR-1 trial, which enrolled 154 patients, showed promising results with 68% of patients achieving sustained clinical complete responses at 12 months. This approval marks a significant milestone in the treatment of advanced rectal cancer, offering new hope to patients with this specific subtype.

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