FDA has accepted for filing with Priority Review the supplemental Biologics License Application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma.
FDA approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the phase I/II CADENZA trial, a global study evaluating the safety and efficacy of Decnupaz for BPDCN.
