Drugs and FDA
FDA approves GSK immunotherapy for some advanced rectal cancers
The approval covers adults with stage II or III locally advanced rectal cancer whose tumors are MSI-H or dMMR, and may let some avoid chemotherapy, radiation and surgery.
The FDA approved GSK’s dostarlimab, sold as Jemperli, for adults with stage II or III locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). MedCity News reported that an FDA-authorized test must identify the genetic signature before treatment.
In a Phase 2 study of 154 previously untreated patients, Time reported that 68% had a complete clinical response at one year. MedCity News reported that almost three-fourths of patients in the study had not needed surgery, radiation or chemotherapy after a median follow-up of more than two years.
The FDA granted accelerated approval based on interim results. MedCity News reported that GSK must submit additional clinical data to show lasting clinical benefit, and that patients in the study continue to be followed.
