FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”
Positive high-level results from the Tropion-Breast02 phase III trial showed Datroway (datopotamab deruxtecan-dlnk) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival compared to investigator’s choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not an option.
