Patients on a combination of toripalimab and RemeGen's anti-HER2 antibody disitamab vedotin fared better than those on a chemotherapy regimen.

Fifteen percent of patients who received Skysona within clinical trials have since been diagnosed with hematologic malignancies.

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.