AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
In MacroGenics’ SOPHIA Phase III study in adults with metastatic HER2-positive breast cancer, the biopharmaceutical company’s Margenza plus chemotherapy failed to show a statistically significant advantage when compared to trastuzumab plus chemotherapy in the intent-to-treat population.
Topline results from the Phase III TULIP study show an antibody-drug conjugate (ADC) from the Netherlands-based Byondis B.V. significantly prolonged progression-free survival (PFS) in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Seattle Genetics announced positive results from the company’s HER2CLIMB Phase III trial of tucatinib in combination with trastuzumab and capecitabine compared to trastuzumab and capecitabine alone in locally advanced unresectable or metastatic HER2-positive breast cancer.
The U.S. drug regulator will give a speedy review to AstraZeneca Plc’s experimental breast cancer treatment trastuzumab deruxtecan.