Source: Healio News
The FDA recently granted breakthrough therapy designation of a HER2-directed antibody drug conjugate for the treatment of certain adults with unresectable or metastatic HER2-low breast cancer.
The designation applies to patients who previously received a systemic therapy in the metastatic setting or experienced disease recurrence during or within 6 months of adjuvant chemotherapy, according to the FDA. It was the top story in hematology/oncology last week.
The FDA also recently granted orphan drug designation to an off-the-shelf chimeric antigen receptor T-cell therapy for adults with advanced