U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA
TEVIMBRA plus ZIIHERA and chemotherapy regimen delivered statistically significant median OS of 26.4 months, an unprecedented result in this challenging disease
Results from the global Phase 3 HERIZON-GEA-01 study demonstrate potential to change clinical practice in advanced HER2+ gastroesophageal adenocarcinoma
Excerpt from the Press Release:
SAN CARLOS, Calif.–(BUSINESS WIRE)–BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:
“HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-containing arm demonstrating an unprecedented 26-month survival benefit. The FDA’s Priority Review designation is a major milestone in our effort to bring better first‑line options to patients with HER2‑positive gastroesophageal adenocarcinoma. We will work in partnership with regulators to support the review process, with the aim of rapidly bringing this new treatment option to patients.”
Data supporting sBLA filing
The sBLA submission is based on the first interim analysis (IA1) of HERIZON-GEA-01, a global Phase 3 clinical trial designed to evaluate ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ GEA.
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