$JAZZ (JAZZ PHARMACEUTICALS) — 8-K: FDA approves Ziihera combos in first-line HER2+ GEA; median OS 26.4 months

The FDA approved two Ziihera-containing regimens for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. Ziihera plus tislelizumab and chemotherapy reduced risk of death by 28% versus trastuzumab plus chemotherapy, with median overall survival of 26.4 months versus 19.2 months. Both Ziihera combinations reduced risk of progression or death by 35%, with median progression-free survival of 12.4 months versus 8.1 months. Jazz will host an investor webcast on Aug. 25 at 4:30 p.m. ET.

The FDA approved two Ziihera-containing regimens for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. Ziihera plus tislelizumab and chemotherapy reduced risk of death by 28% versus trastuzumab plus chemotherapy, with median overall survival of 26.4 months versus 19.2 months. Both Ziihera combinations reduced risk of progression or death by 35%, with median progression-free survival of 12.4 months versus 8.1 months. Jazz will host an investor webcast on Aug. 25 at 4:30 p.m. ET.