FDA APPROVED AN IMMUNOTHERAPY THAT MAY LET SOME RECTAL-CANCER PATIENTS SKIP SURGERY.
In an ongoing trial, nearly three-quarters had not needed the usual treatments after a median of more than two years.
The FDA approved dostarlimab-gxly alone for adults with untreated Stage II or III mismatch-repair-deficient or microsatellite-instability-high rectal cancer.
WHAT HAPPENED
In the ongoing AZUR-1 Phase 2 study of 154 patients, treatment produced sustained clinical complete responses. After a median follow-up of more than two years, nearly three-quarters of participants had not needed surgery, radiation, or chemotherapy. This tumor subtype accounts for about 3% of locally advanced rectal cancers.
WHY THIS IS HOPESLOP
For the eligible minority, the possibility is unusually concrete: treat the tumor without immediately sacrificing an organ or enduring the full standard regimen. The evidence is promising, not final; the approval is accelerated, follow-up continues, and immunotherapy can cause serious immune-related reactions.
ORIGINAL SOURCEU.S. Food and Drug AdministrationRead the original report
A DAILY ALLEGATION OF PROGRESS.
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